Quality Engineer

Title: Quality Engineer
Location: Doylestown, PA

We are seeking a Quality Engineer to join a local medical device company and play a key role in ensuring the compliance and robustness of their products and processes. This position will focus on quality engineering activities in product development, manufacturing, and supplier management within a regulated environment.

Key Responsibilities:

• Ensure protocols, reports, and records related to product and process development are critically reviewed for content and compliance.
• Provide quality engineering expertise to drive continuous improvement in design, process robustness, and material supply.
• Optimize, align, and control inspection and measurement methods across the supply chain.
• Support operations, engineering, and purchasing departments in managing non-conforming materials and implementing immediate mitigation actions.
• Own the process of non-conforming products (NCs), supplier corrective actions (SCARs), and corrective and preventive actions (CAPAs), ensuring effective resolution and documentation.
• Lead and support root cause investigations, corrective action implementation, and verification of effectiveness.
• Monitor trends, provide periodic reports, and ensure documentation is complete at closure.
• Ensure suppliers meet company requirements and are selected, qualified, evaluated, and maintained per internal procedures.
• Conduct supplier audits and periodic visits to maintain oversight and drive supplier maturity improvements.

Qualification:

• Bachelor's degree (or equivalent experience) in a relevant technical field.
• 3+ years of experience in quality engineering within a regulated environment (preferably medical devices).

• Knowledge of mechanical, plastics, and/or electrical parts and their manufacturing methods.
• Understanding of ISO 9001, ISO 13485, or similar quality system requirements.
• Experience in product development, production, and/or supplier management.
• Ability to conduct audits, preferably against ISO 13485.
• Background in quality improvement projects and application of statistical methods in quality control.
• Experience with inspection and measurement methods to assure material and product quality.