Senior Quality Engineer
Overview: EPM is hiring on behalf of a leading medical device manufacturer recognized for its innovation and excellence in producing active medical devices and software solutions. This hybrid position offers a unique opportunity to play a pivotal role in ensuring the quality and compliance of cutting-edge products that advance healthcare worldwide. Key Responsibilities: Oversee and enhance quality assurance processes for active medical devices and associated software, ensuring compliance with FDA, ISO 13485, IEC 62304, and other applicable global standards. Participate in product lifecycle activities, including design verification, validation, and risk management, to ensure quality integration from concept to post-market. Lead root cause analysis, non-conformance investigations, and corrective and preventive action (CAPA) activities. Collaborate cross-functionally with R&D, manufacturing, and regulatory teams to ensure adherence to quality standards throughout development and production. Conduct and support internal and external audits, including supplier audits, ensuring robust documentation and adherence to applicable regulations. Provide quality input for software lifecycle management, including configuration control, validation, and cybersecurity compliance. Stay updated on industry trends, emerging regulations, and best practices to guide continuous improvement initiatives. Mentor and train junior QA staff on best practices, standards, and regulatory requirements. Qualifications: Bachelor's degree in Engineering, Life Sciences, or a related field (Advanced degree preferred). Minimum of 5 years of experience in quality assurance for active medical devices and software. Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, IEC 62304 (software lifecycle), and risk management standards such as ISO 14971. Experience with software quality assurance, validation, and cybersecurity considerations for medical devices. Proven track record of working in hybrid or cross-functional environments with a focus on quality and compliance. Excellent problem-solving, analytical, and communication skills. Certifications in quality management or auditing (e.g., ASQ Certified Quality Engineer, Certified Quality Auditor) are a plus.
Negotiable
United States of America
Apply
Associate Director/Director Analytical Sciences & Technology
Our client is a research organisation that develops vaccines and biologics. They are currently looking for a leader for their Analytical Sciences & Technology team to drive the development and implementation of analytical controls activities. Responsibilities: Develop and manage strategies for the entire lifecycle of analytical methods, ensuring compliance with regulatory standards. Provide strategic leadership for AS&T and QC systems, overseeing processes, programs, and procedures. Collaborate with various departments to support scientific analysis and manage external laboratory activities. Ensure QC laboratory operations comply with GMP standards, and review and approve all analytical documents. Monitor AS&T and QC program performance, address laboratory issues, and drive continuous improvement. Lead and mentor the AS&T team, contributing to strategic planning and quality standards as part of the Quality Leadership Team (QLT). Requirements: Bachelors in Science, Engineering or related technical field. Masters or PhD preferred. At least 10 years of experience in CMC, Analytical Sciences, Quality Control or related Familiar with regulatory requirements Strong GMP knowledge and experience Strong leadership experience Strong and effective communication skills If you are interested, please apply with your CV attached.
Negotiable
Singapore
Apply
QC Senior Associate
Join a global biotechnology company as a QC Senior Associate in Singapore! Are you passionate about quality control and quality management system? Do you want to be part of a leading company in the biopharmaceutical industry, known for its cutting-edge manufacturing capability and innovative human therapeutics? If so, we have the perfect opportunity for you! Position: QC Senior Associate Location: Singapore About our Client: Our client is a global multinational company at the forefront of the biopharmaceutical industry. Their commitment to innovation and excellence has made them a leader in biotechnology breakthroughs and human therapeutics. Key Responsibilities: Plan, schedule, perform analytical testing and approval of test results on raw materials, water, in-process control, drug substance and stability samples in GMP pharmaceutical environment. Troubleshooting issues related to analytical testing, techniques and equipment Conduct laboratory investigations and assist in timely closure of investigations, CAPAs and deviations Support method verification and method validation/transfer for new product introduction (when required) Train new/ junior laboratory staff and ensure all staff are appropriately trained and qualified to execute the duties assigned to them with respect to the job Support laboratory operations including but not limited to equipment qualification, calibration and maintenance, reagent/buffer preparation, chemicals/consumables inventory, laboratory housekeeping and document archival duties. What We're Looking For: Master's degree in Chemistry, Biochemistry, or related technological field. Bachelor's degree in Chemistry, Biochemistry or related technological field and 2 years of directly related experience. Associate's degree in Chemistry, Biochemistry or related technological field and/or 6 years of directly related experience. High school diploma in Chemistry, Biochemistry or related technological field / GED and 8 years of directly related experience. Preferred 4 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry and laboratory testing experience preferred. Experience in laboratory asset management, method qualification and transfers. Strong technical knowledge in and experience with the following QC Chemistry/ Biochemistry/ Raw material testing methods and equipment is required: Immunosorbent Assay/Cell based Bioassay: Potency, Host Cell Proteins, ELISA. Chromatography: UPLC, HPLC, LC-MS, GC-HS. General Chemistry: Capillary Electrophosis, LOD, Autotitration, KF, Optical Rotation, FT-IR, Conductivity, TOC, pH, wet chemistry. Why Join Us? Innovative Environment: Work with cutting-edge technology and innovative products. Professional Growth: Opportunities for continuous learning and career advancement. Impactful Work: Contribute to products that improve patient outcomes and healthcare quality. Dynamic Team: Collaborate with a team of dedicated professionals who are passionate about what they do. If you're ready to take your career to the next level and make a significant impact in the medical device industry, we want to hear from you!
Negotiable
Singapore
Apply
QC Specialist
Join a global biotechnology company as a QC Specialist in Singapore! Are you passionate about quality control and quality management system? Do you want to be part of a leading company in the biopharmaceutical industry, known for its cutting-edge manufacturing capability and innovative human therapeutics? If so, we have the perfect opportunity for you! Position: QC Specialist Location: Singapore About our Client: Our client is a global multinational company at the forefront of the biopharmaceutical industry. Their commitment to innovation and excellence has made them a leader in biotechnology breakthroughs and human therapeutics. Key Responsibilities: Ensure laboratory systems and operations meet GMP compliance and Amgen Quality Management System requirements. Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply. Provides technical support to ensure the manufactured products meet the applicable regulatory standards and guideline with respect to Quality Control. Responsible for planning, scheduling, and performing laboratory testing and approval of test results on in-coming raw materials, utility water, In-process control, drug substance intermediate, final release, stability, and plant cleaning samples in a GMP pharmaceutical environment. Conduct or lead laboratory investigations and assist in timely closure of investigations, CAPAs and deviations. Support laboratory operations including but not limited to equipment qualification, calibration, cleaning and maintenance, reagent/buffer preparation. What We're Looking For: Doctorate degree in Chemistry, Biochemistry, Life Science, or related technological field. Master's degree in Chemistry, Biochemistry, Life Science or related technological field and 2 years of directly related experience. Bachelor's degree in Chemistry, Biochemistry, Life Science or related technological field and 4 years of directly related experience. High school diploma / GED in Chemistry, Biochemistry or related technological field and 8 years of directly related experience. 6-8 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry and laboratory testing experience preferred. Strong technical knowledge in and experience with the following QC Chemistry/ Biochemistry testing methods and equipment is required: Immunosorbent Assay/ Cell based Bioassay: Potency, Host Cell Proteins, ELISA. Chromatography: UPLC, HPLC, LC-MS, GC-HS. General Chemistry: Capillary Electrophoresis, ICP-MS, LOD, Autotitration, KF, Optical Rotation, FT-IR, Conductivity, TOC, pH, wet chemistry. Why Join Us? Innovative Environment: Work with cutting-edge technology and innovative products. Professional Growth: Opportunities for continuous learning and career advancement. Impactful Work: Contribute to products that improve patient outcomes and healthcare quality. Dynamic Team: Collaborate with a team of dedicated professionals who are passionate about what they do. If you're ready to take your career to the next level and make a significant impact in the medical device industry, we want to hear from you!
Negotiable
Singapore
Apply
Quality Director
Our client is a global leader in life sciences and biopharmaceuticals, offering unparalleled opportunities to impact healthcare. The Quality Director will play a crucial role in leading and inspiring quality teams, ensuring the highest standards of quality, directly impacting the safety and efficacy of life-saving treatments for patients worldwide. Roles and Responsibilities: Lead and Inspire Teams: Cultivate high-performing teams that excel in meeting business demands while upholding quality and regulatory standards. Global Collaboration: Engage with international teams and key stakeholders to harmonize quality strategies across the globe. Resource Management: Strategically manage resources and financial planning to meet both business and quality objectives. Audit Readiness: Guarantee the site is always prepared for client audits, internal audits, and regulatory inspections. Investigate Issues: Lead thorough investigations into events, complaints, and data audits to ensure resolution. Ensure Compliance: Uphold rigorous regulatory standards in all operations and reporting. Risk Mitigation: Proactively identify and address key risks through effective collaboration. Document Review: Approve and oversee critical GxP documents and quality records with precision. KPI Reporting: Deliver insightful performance metrics to senior management. Qualifications B.Sc. in Life Sciences, MSc or PhD preferred. 10+ years of management experience in quality. 10+ years in a GMP and GLP environment in a regulated industry (pharmaceutical, biopharmaceutical preferred). Strong global mindset, flexibility to work across time zones, relationship-building, negotiation, and change management skills.
Negotiable
Singapore
Apply
Quality Manager
Title: Quality Manager Location: Albany, OH (Can Provide Relocation) A leading pharmaceutical company just launched a brand new 503b facility and is rapidly expanding their site. They are looking for a Quality Manager to lead QA and QC activities for this new site. Responsibilities: Review and approve Quality documentation (batch records, SOPs, deviations, change controls, OOS investigations, etc.) Create annual product reviews, review/approve label changes Provide assistance and leadership in regulatory inspections Oversee incoming materials, sample reserve, and sterility assurance programs Support vendor management and assist with vendor qualification activities Host FDA audits and Regulatory inspections Qualifications: Bachelor's degree with 7+ years of relevant experience Ability to lead QA/QC activities and work in a fast-paced startup environment Must have experience with batch disposition and sterility Must have experience hosting FDA audits and regulatory inspections If this sounds of interest, please don't hesitate to apply!
Negotiable
Swedesboro
Apply
Manager, Quality Control
Manager, Quality Control Purpose and Scope Join a globally renowned pharmaceutical firm specializing in cutting-edge long-acting injectable drug delivery systems. Their team is built on dedication to supporting partners, patients, and healthcare providers. Oversee the creation and execution of policies, processes, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products. Provide leadership and management to the Quality Control Chemistry team, including investigators, instrumentation lifecycle specialists, sampling personnel, and the laboratory administrator. Essential Duties & Responsibilities Manage Laboratory Operations: Oversee daily QC Chemistry lab operations, ensuring quality standards and project timelines are met. This includes work prioritization, coordination with stakeholders, and communication with leadership. Compliance and Documentation: Supervise the generation, documentation, and compliance of deviations, investigations, CAPA change controls, and instrumentation. Ensure compliance with sample submission forms, periodic reviews, and regulatory requirements. Change Management and Continuous Improvement: Author, review, and approve controlled documents and change controls. Lead the department in evaluating and implementing new systems and training for continuous improvement. Resource and Budget Management: Review and approve purchase requests and invoices, ensuring budget adherence. Identify cost-saving measures and manage resources to support laboratory processes. Team Leadership and Development: Provide guidance and mentorship to staff, participate in hiring and retention, and recognize top-performing talent. Foster an atmosphere of teamwork and respect, and ensure technical and transferable skill development. Knowledge, Skills & Abilities Leadership and Team Management: Excellent leadership and supervisory skills with the ability to coach, mentor, and develop staff. Demonstrated ability to create and maintain highly functioning teams and foster an atmosphere of teamwork and respect. Regulatory and Compliance Expertise: Expert knowledge of regulations related to deviations, investigations, CAPA, change control, and instrumentation. Extensive knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211), GMPs, GLP, and cGMP for conformance to US, EU, and ROW standards. Technical Proficiency: Proficient in computer systems for sample tracking, laboratory equipment, raw data handling, and storage. Experience in conducting investigations, writing deviations, implementing CAPA, and initiating change controls. Ready to make a difference? Join and be part of a team that's transforming the future of healthcare.
US$120000 - US$135000 per year
Colorado
Apply
Sr. Design Assurance Engineer
Title: Senior Design Assurance Engineer Location: Marlborough, MA (On-Site) A MA-based company that develops innovative medical device laser solutions is rapidly growing and seeking additional support on their Quality team. They are looking for a Senior Design Assurance Engineer to lead NPD activities from start to finish as they continue to create new products. Responsibilities: Conduct product design control activities for both new and ongoing product development projects. Support risk analysis efforts, including design and process Failure Modes and Effects Analysis (FMEA). Assist with Process/Design Validation and Verification activities, including software validation and Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities. Aid Design Engineering in creating Design History and Technical Files. Coordinate with third-party test houses for compliance testing of IPG products. Assist the regulatory department with submissions to the FDA, CE, and other regulatory bodies. Perform other essential duties as assigned. Qualifications: Bachelors degree with 7+ years of experience within medical device Experience working with a product from design to commercialization Expertise with design controls and risk management Must be authorized to work in the US without sponsorship If this sounds interesting, please apply for more information!
Negotiable
Marlborough
Apply
CQV
Job Title: Freelance CQV Engineer Start Date: January 2025 Contract: 12 Months Location: Denmark I am working with a big pharma company and looking for an experienced CQV Engineer to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing systems, utilities, and equipment. The ideal candidate will have 5-10+ years of experience in CQV within Downstream processes and mAb processes, Key Responsibilities: Lead CQV activities for manufacturing systems (HVAC, water, production equipment). Develop and review IQ, OQ, PQ protocols and reports. Collaborate with engineering, quality, and manufacturing teams. Ensure compliance with FDA, EU GMP, and internal SOPs. Troubleshoot CQV issues and implement corrective actions. Maintain cGMP-compliant documentation and conduct risk assessments. Requirements: 5-10+ years in CQV, with experience in Downstream and mAb processes. Strong regulatory knowledge (FDA, EU GMP). Excellent documentation, problem-solving, and team collaboration skills. If you're interested, please share a time to discuss further!
Negotiable
Danmark
Apply
Principal/Sr Principal Quality Engineer
Responsibilities: Oversee design assurance and development tasks for New Product Development, including risk evaluations, engineering studies, feasibility assessments, drawing analysis, and statistical evaluations. Ensure compliance with relevant regulatory frameworks, such as FDA, EU MDR, and ISO standards, across all stages of product development. Create and validate advanced experiments and testing protocols to enhance product design and manufacturing processes based on engineering principles. Identify and address quality and regulatory concerns throughout the product lifecycle, providing detailed analysis and reports prior to product launch. Evaluate and audit suppliers to verify materials and components meet strict quality standards, implementing corrective actions as required to ensure compliance. Qualifications: Bachelor's degree in Engineering or a related field; advanced degree preferred. At least 7 years of quality engineering experience in the medical device industry, ideally in cardiac ablation or structural heart technologies. Expertise in quality assurance, control, and process optimization, with strong proficiency in tools like FMEA, CAPA, SPC, Six Sigma, and Minitab. Strong analytical and problem-solving skills, including experience with root cause analysis and corrective action. Hands-on experience with validation processes (IQ/OQ/PQ), product testing, and statistical methods. Proven success in leading quality initiatives and driving continuous improvement, with a focus on risk management and compliance. Excellent communicator, capable of working effectively with cross-functional teams, suppliers, and regulatory agencies. For any questions please reach out to adam.tizabi@epmscientific.org to learn more about this oppurtunity!
US$130000 - US$170000 per year
Irvine
Apply
