QC Supervisor - 2nd shift
Andover, MA 01810 US
QC Inspection Supervisor - Second Shift
ESSENTIAL TASK AND DUTIES INCLUDE:
- Supervise growing team of quality personnel responsible for inspecting accessories and sub-assemblies. This includes hiring, developing, scheduling, and directing employees, communicating expectations, managing performance and addressing questions or concerns. This position may also include supervision of other 2nd shift personnel as needed by the business.
- Lead efforts to ensure all production and test related activities are executed in a timely manner to satisfy the Company’ s production schedule and quality standards (cGMP’ s, QSR and ISO requirements).
- Monitor the accuracy, completeness, and timeliness of inspection processes.
- Ensure inspection team members are appropriately trained for test activities, as well as on company Standard Operating Procedures and safety procedures, as required.
- Ensure inspection, quarantine and production areas are maintained in an orderly manner, inspection and production documentation is accurate and up to date.
BACKGROUND AND QUALIFICATIONS:
- Minimum of 7 years as a Quality Engineer in the medical device manufacturing industry, including 4 years with responsibility for product quality or quality systems.
- 1-2 years’ experience managing in an FDA/ISO regulated Medical Device company
- A working knowledge in the following areas:
- 21 CFR Part 820, ISO 13485 auditing
- Nonconformance processing
- Mechanical drawing reading, including geometric tolerance
- SPC, basic statistical tests and C=0 sampling plan
- Must be detail oriented with strong organizational skills.
- Strong leadership and interpersonal skills, with willingness to be held accountable for deliverables.
- Outstanding ability to communicate clearly and effectively(oral and written).
- Must have effective analytical and decision making skills, criteria for obtaining results.
- Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities and multiple priorities. Must be results driven.
- Act independently to identify, prioritize and resolve issues as they arise with minimal supervision.
- BS in an engineering discipline, experience in a related field preferred; plus a minimum of 1-2 years’ experience in managing in an FDA/ISO regulated Medical Device industry or equivalent combination of education and experience