The Manager of Quality Engineering has oversight of the application of quality engineering principles at RefleXion Medical with respect to manufacturing processes, supplier management, incoming inspection, new product introduction, and sustaining engineering. Responsibilities include oversight of metrology, gage R&R, test method validation, DOE, and statistical techniques. This position interfaces with Materials, Research and Development, NPI, Operations, Product Engineering, Clinical and Regulatory Affairs departments regarding design control, production and post market activities. A working knowledge of risk management and production processes necessary to build highly complex capital equipment is key in this role. This individual is expected to comfortably operate in a fast paced, dynamic and highly collaborative environment where “outside the box thinking” is the norm.
- Manage direct reports, recruit new talent, coordinate daily activities, establish functional goals, provide mentoring/coaching and perform performance reviews.
- Work with Operations and Manufacturing Engineering to drive continuous improvement through business and quality objectives and resolve issues that could impact product quality or regulatory compliance.
- Provide Quality Engineering support for production; addresses non-conformances through the NCR/CAPA system - driving escalation when risk level warrants it - and participates in complaint investigations.
- Work with Manufacturing and Service organizations to resolve technical and documentation issues.
- Collaborate with cross-functional teams on new product introductions and sustaining projects with a focus on Design for Manufacturability / Testability / Reliability and equipment qualification (IQ/OQ/PQ)
- Drive risk-based evaluation of data and implementation of processes using a risked based approach and sound statistical techniques.
- Participate in management review meetings; compile and analyze quality metrics and data with the objective of establishing goals and identifying trends.
- Provide support for internal audits, third party audits, FDA inspections, and Notified Body audits.
- Provide guidance about statistical methods for Sampling, Acceptance, DOE, Statistical Process Control, Root Cause Analysis, and/or control charts.
- Lead cost reduction projects, using Six Sigma and Lean Business methodologies as well as supporting projects driven by other functions where quality oversight is needed.
- Interface with all internal departments to proactively identify potential issues and develop solutions to minimize or prevent adverse effects on products.
- Assure finished products conform to regulations and applicable standards satisfying the QSR, ISO, and other relevant requirements.
- Provide input to department budgets and drive improvements leading to enhanced efficiencies.
- Perform other duties as assigned.
- BS in Engineering or life sciences. MS in Engineering or life sciences preferred.
- 7-10 years of Quality-related experience in the Medical Device industry and 3-7 years of management experience. Experience with capital equipment and within a start-up environment preferred.
- Solid organizational, analytical and problem-solving skills.
- Strong computer skills, particularly with PLM, ALM, ERP/MRP, MS Office and Adobe Acrobat.
- Excellent interpersonal, communication and presentation skills, both verbal and written.
- Solid understanding of QSR, MDD/MDR, ISO 13485:2016, and 14971:2012. Familiarity with IEC 62304, 62366 and 60601 standards preferred.
- Additional peripheral experience in Engineering and/or Product Development, and manufacturing for capital commercial medical devices is preferred.
- Experience performing PFMEA, IQ, OQ, PQ, PPQ, and TMV.
- Proven experience with data driven engineering methodologies such as DOE, GRR, SPC and 6 Sigma techniques.
- Significant experience interacting with suppliers to ensure product conformance, cost effectiveness and outsourcing initiatives.
- Lead Auditor certification and/or ASQ certification preferred