Quality Assurance Specialist, Medical and Health Services
Company: TUV SUD America
Posted on: January 15, 2020
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,
- 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
- Release certificates as required.
- Identify, plan, and implement improvements to the existing CAPA
- 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
- Overhaul the management review program, introducing more
objectivity in inputs, tracked actions, objectives, and KPI
- 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
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
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:
EEO is the Law Poster Supplement:
Pay Transparence Policy Statement:
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
- 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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