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Quality Assurance Specialist, Medical and Health Services

Company: TUV SUD America
Location: Peabody
Posted on: January 15, 2020

Job Description:

Quality Assurance Specialist, Medical and Health Services 123984 Full time regular Professionals 3 - 5 years of experience Medical Devices & Healthcare





Your responsibilities will include, but are not limited to







- Provide support to internal and external stakeholders in interpreting medical device standards (e.g., ISO 13485, MDSAP, MDD)
- Analyze audit registrations and contracts, ensuring that certification (quality and regulatory) requirements are considered prior to audit start.
- Review audit report packages to verify applicable review criteria were met.
- Release certificates as required.
- Identify, plan, and implement improvements to the existing CAPA system.
- Plan and implement a business unit and department measurement scheme which would allow for standardized monthly metric generation and reporting on the health of various aspect of the certification quality system.
- Overhaul the management review program, introducing more objectivity in inputs, tracked actions, objectives, and KPI reporting.
- Drive quality-first thinking within Medical and Health Services division and introduce related communication strategies.
- Improve the internal audit program implement a process-based instead of checklist-based auditing scheme and risk-based criteria for audit frequency and requirements.
- Map internal processes and drive sharing of process knowledge breaking any existing silos.
- Track training records and continuous development hours; involve external stake-holders in this process as required.
- Plan and implement a Certification PFMEA.
- Continuously look for improvement in business processes identify, champion, and maintain said improvements.
- Other tasks as needed














For over 30 years, T V S D has provided market access solutions and expert partnership for medical device manufacturers and suppliers. Our dedicated team of over 500 medical experts, engineers, and doctors, positioned all over the globe, provide assessments that cover the full life cycle of your medical device - including initial product designs, risk management, clinical and regulatory.


The Quality Assurance Specialist performs quality management and certification activities required for the continued success of the TUV SUD certification quality programs. The opportunity includes interfacing responsibilities with external and internal customers including auditing bodies business and service units, and other department members. Continuous improvement thinking is encouraged.


T V S D America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.


For more information on applicable equal employment regulations, please refer to the following:


EEO is the Law Poster: www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf


EEO is the Law Poster Supplement: www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf


Pay Transparence Policy Statement: www.dol.gov/ofccp/PayTransparencyNondiscrimination.html








This job may be for you if you have:


- BS or MS Degree in a science related field (biotechnology, biology, chemistry, microbiology, electrical engineering, mechanical eingeering, etc.)
- Formal training in Quality Management
- 5+ years industrial medical device experience, at least 3 of them as Quality Manager / Regulatory Affairs / Quality Assurance or related.
- 2+ years auditing experience to all or some of ISO 13485, MDD/IVDD/AIMDD, CMDCAS, MDSAP.
- Lead Auditor Certification.
- Knowledge of the following is beneficial: ISO 17021-1(-3), IAF MD 9, IAF MD 7, IMDRF/MDSAP N3, IMDRF/MDSAP N4










US-MHS-CRT Peabody/ New Brighton (MN) Massachusetts United States

Keywords: TUV SUD America, Peabody , Quality Assurance Specialist, Medical and Health Services, Healthcare , Peabody, Massachusetts

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