Johnson Service Group, a nationally award-winning staffing firm, has an immediate opportunity for a Quality Specialist with TUV Audit & Compliance experience for a global medical device client in Charlton, MA.
Contract | Onsite | $38 - $45/Hr.
Summary: Responsible for supporting product and process quality through continuous improvement and new product development. Duties include process validation, defect investigation and corrective actions, new product evaluation, conducting internal audits for ISO and FDA/QSR compliance, training personnel, and improving testing and measurement methods.
Key Responsibilities
- Oversight of various quality systems including, but not limited to, nonconforming material, audits, management review, external standards, and/or document management.
- Identification of quality issues and resolution support.
- Review of test protocols and/or process validation protocols and reports.
- Preparation and analysis of quality data and metrics.
- Support of internal audits of systems, products and processes.
- Preparation and support of external/regulatory audits.
- Preparation of engineering changes.
- Provide training and direction to manufacturing and QA personnel.
- Participate in MRB meetings.
- Support nonconforming material disposition.
- CAPA maintenance including investigation support, and/or corrective action ownership.
- Support quality/manufacturing related improvement efforts.
Qualifications
- BS Degree in a Technical /an Engineering discipline or equivalent relevant experience in lieu of degree.
- 3 years minimum experience within manufacturing environment, with experience in manufacturing, quality, or process engineering preferred. Medical device experience is preferred. CQE certification a plus.
- Must have knowledge of ISO 13485 and FDA/QSR Regulations
- Strong computer skills with software applications for Microsoft Windows including Excel, Word and Minitab.
- Knowledge of Six Sigma and Lean manufacturing preferred.
- Ability to communicate effectively with personnel at all levels both verbally and in writing.
- A self-starter able to function independently with minimum direction.
#D800
JSG offers medical, dental, vision, life insurance options, short-term disability, 401(k), weekly pay, and more. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.