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Technical Reviewer - Medical and Health Services

Company: TUV SUD America
Location: Peabody
Posted on: January 5, 2020

Job Description:

Technical Reviewer - Medical and Health Services 125999 Full time regular Professionals 3 - 5 years of experience Medical Devices & Healthcare Your responsibilities will include, but are not limited to:



- Perform technical assessments of audit and project files with certification decision based on requirements from ISO 13485, ISO 9001, MDSAP, AIMDD/MDD/IVDD.
- Answer internal and external requests regarding regulatory requirements.
- Perform evaluations of regulatory submissions including: Design Dossier (EU Directives), Technical File Review (EU Directives).
- Continuously look for improvement in business processes and software solutions identify, champion, and maintain said improvements.
- Keep abreast of present and pending regulatory requirements, standards and T V S D America service capabilities through internal training sessions, external seminars, and reading of scientific articles.
- Optional and as needed, perform regulatory audits of clients per European Medical Device Directives (MDD/AIMDD/ IVDD), Medical Device Single Audit Program (MDSAP), and International quality system standards (e.g. ISO 13485) as well as internal Notified Body and T V S D America criteria including all related tasks, such as planning, reviewing corrective actions, preparing reports and audit documentation for submission to the certification committee of the Notified Body.
- Generate metrics as required.
- Handle contract review and audit registration, as required.
- Communicate in a prompt, courteous and effective manner with internal and external customers in all circumstances including providing information, answering questions, and relaying messages.
- Other tasks as needed







Immediate opening for a Technical Reviewer based in Peabody, MA, New Brighton, MN, San Diego, CA or a Home Office.


The Technical Reviewer performs final review and release of technical audit reports for TUV SUD America audits. 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. The successful candidate is detail-oriented, enthusiastic, able to work with minimal supervision, and enjoys coming up with creative solutions to ever more creative challenges.


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.

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 links below:


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:



- BS or MS Degree in a science related field (biotechnology, biology, chemistry, microbiology, electrical engineering, mechanical engineering, etc.)
- Formal training in Corrective and Preventive Actions, and Root Cause Analysis
- 5+ years industrial medical device experience, at least 3 of them as Quality Manager / Project Manager / Engineer / 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 (including surveillance and (re)certification audits performed).
- Experience working in an accredited Certification Body is preferred.
- Demonstrated ability to work independently and in a collaborative team environment;
- Passion for working in the medical device industry;
- Demonstrated, excellent oral and written communication skills;
- Self-starter with a positive outlook and motivated attitude; a commitment to self-improvement;
- Ability to successfully keep track of several projects at one time, adhere to tight deadlines and maintain a positive, helpful attitude;
- Represent T V S D products and services in a professional manner;
- Accurate, clear, and timely communicate of information, upward and lateral, including verbal, written and listening skills;
- Reliable judgment that is consistent, adaptable to unusual situations, realistic, common sense approach to job and problems;
- Willingness to consider other s ideas and to work with others as part of a team;
- Adaptable and willing to shift to other duties to meet changing work-loads.

















US-CRT-MA Boston / Peabody Massachusetts United States Home Office Massachusetts United States

Keywords: TUV SUD America, Peabody , Technical Reviewer - Medical and Health Services, IT / Software / Systems , Peabody, Massachusetts

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