Vacancy expired!
- Full-time/Permanent position
- Located in Collier County, FL. (Onsite role)
- Competitive salary
- Amazing benefits and generous relocation package
- Must have 5+ years of experience in a Quality Control or Quality Assurance position, preferably in a medical device company
- Must have SPC (Statistical Process Control) experience
- Experience in process improvement (i.e.: Lean, Six Sigma) and problem solving (i.e.: RCA, DMAIC, 5 Whys) training
- BS Engineering or Engineering Technology required
- A background in Biotech, Med Device, or Pharma Automation is preferred
- 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
- 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.
- Bachelor’s degree in an Engineering or Engineering Technology discipline.
- 5 years of experience in a Quality Control or Quality Assurance position required, preferably in a medical device company.
- ID: #48702043
- State: Florida Colliercounty 00000 Colliercounty USA
- City: Colliercounty
- Salary: Depends on Experience
- Job type: Permanent
- Showed: 2023-01-20
- Deadline: 2023-03-07
- Category: Et cetera