MEDICAL DEVICE Sr 1 Quality Engineer - Manufacturing
seeking a Sr 1 Quality Engineer – Manufacturing who works directly with the Manufacturing & Quality Engineering teams. You will be responsible for ensuring the suitability and effectiveness of the manufacturing site QMS by measuring and monitoring process effectiveness, driving and implementing improvements to QS processes, facilitating CAPAs and CAPA Review Board, administration and maintenance of internal and external audits, investigation/resolution of quality issues, and development of QS processes. Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree in Engineering or Engineering Technology discipline will be essential for this position.
Essential Duties and Responsibilities:
- Participates in the development of medical devices and components from design initiation through design transfer and by representing Quality Assurance for manufacturability in all design and development project teams.
- Participates in all manufacturing activities to assure compliance of design specifications.
- Leads development of quality plans of new product introductions based on design specifications, PFMEA, and control plans.
- Works with design team and assist/provide feedback on design specifications and improvements.
- Evaluates and develops effective and efficient methods of testing and inspection of products.
- Utilizes problem solving tools and techniques and apply risk based approach to problem solving.
- Determines necessity of testing and initiates testing by preparing test and inspection plans and identifying and obtaining required test fixtures and test/inspection instrumentation.
- Initiates new projects and acts as the project leader for key initiatives, identifies best practices.
- Provides technical support on manufacturing technical issues.
- Performs quality trending and leads/supports process improvement initiatives.
- Approves manufacturing product and process changes and assures the change management is controlled, adequate, and documented.
- Ensures information and documentation is consistently accurate.
- Responsible for MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations.
- Provides input and direction to other members of the quality assurance department to assist them in their assignments and provide them with learning experience.
- Supports manufacturing suppliers with assistance in on-site resolution of quality and process related issues and corrective and preventive actions.
- May supervise other engineers, technicians, and support personnel.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor’s degree required in an Engineering or Engineering Technology discipline.
- 5 years experience in a Quality Control or Quality Assurance position required, preferably in a medical device company.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Working knowledge of risk assessments, design control requirements, PFMEAs, control plans, quality plans, testing and inspection equipment and techniques.
- Manufacturing process knowledge.
- Technical knowledge in development methodologies, design, project implementation, including, but not limited to GD&T, DOE, verification, and validation.
- SPC (Statistical Process Control) knowledge.
- Strong communication skills and ability to communicate effectively with technical and non-technical staff.
- Project management skills preferred.
- Recognized process improvement (i.e.: Lean, Six Sigma) and problem solving (i.e.: RCA, DMAIC, 5 Whys) training preferred.