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.
