Quality Manager
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Swiftwater, PA 18370
Description:
Responsibilities:
- Coordinates design review meetings to review all quality aspects of new products. Interfaces with Product Development Engineers to ensure quality considerations during the concept stage.
- Support Design Control activities by ensuring compliance with FDA and international regulations.
- Lead and participate in Design Failure Modes and Effects Analysis (DFMEA) and risk assessments.
- Review protocols and participate in V&V planning to ensure alignment with product requirements.
- Participate in protocol review and support testing strategy, ensuring robust verification and validation processes.
- Support Design Control activities by ensuring compliance with FDA and international regulations.
- Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In
- Process and Final Inspection procedures and operator self-inspection procedures.
Works with other Quality Engineers and the Metrology Lab personnel on the development of all product gaging. - Support the development and review of process and equipment validation/qualification (IQ/OQ/PQ) and MSA of internal processes.
- Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control.
- Interfaces with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
- Assists with complaint investigation and documentation interfaces with Regulatory Affairs to support UL, IEC, and FDA submissions. Participates in internal audits conducted by internal employees and regulatory agencies.
- Develop and execute supplier qualification processes, including supplier contracts and PPAPs.
- Manage and drive timely resolution of nonconformances (Company) and corrective & preventive actions (CAPAs).
- Bachelor's degree in engineering, Quality, or a related field (Master's preferred).
- 5+ years of experience in medical device quality engineering or a related field.
- Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).
- Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
- Proficiency in statistical analysis tools (Minitab, JMP, Excel) /and problem-solving methodologies (8D, DMAIC).
- Certified Quality Engineer (CQE) or Six Sigma certification is a plus.