PeabodyRecruiter Since 2001
the smart solution for Peabody jobs

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:

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 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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Healthcare Jobs

Associate Veterinarian - Plymouth, IN
Description: Seven Oaks Veterinary Clinic is seeking an Associate Veterinarian to join our growing team Inviting, caring, reassuring, warm, supportive, and nurturing are words to describe Seven Oaks Veterinary (more...)
Company: Get a Vet Staffing
Location: Plymouth
Posted on: 01/19/2020

Medical Assistant/Practice Assistant
Description: Apply NowApply LaterMedical Assistant/Practice AssistantDepartment Description:BIDHP-Specialty is located on Obery Street in Plymouth, MAJob Location:Plymouth, MAReq ID:32831BRJob Summary:Reports to: (more...)
Company: Beth Israel Deaconess Medical Center
Location: Plymouth
Posted on: 01/19/2020

CNA JOB FAIR - Highly Competitive New Rates - January 9am-4pm
Description: CNA JOB FAIR - Highly Competitive New Rates - January 14th 9am-4pm CNA JOB FAIR - Highly Competitive New Rates - January 14th 9am-4pm We just increased our pay rates last week Come and Join Us Be (more...)
Company: Erickson Living
Location: Peabody
Posted on: 01/19/2020

Home Health Aides - VNA Services (Upper Cape, Mid-Cape, Lower & Outer Cape)
Description: OverviewWhy Choose The Overlook Visiting Nurses Association This position is a Homecare position ul li The Overlook offers a great working environment and each employee's contribution is valued (more...)
Company: Plymouth, MA
Location: Plymouth
Posted on: 01/19/2020

Correctional Medicine Licensed Practical Nurse - full time nights displayid:19-72093 Needed
Description: Correctional Medicine opening in Plymouth, Massachusetts. This and other lpn/lvn jobs brought to you by Overview Our Licensed Practical Nurse/Licensed Vocational Nurse LPN/LVN is (more...)
Company: WellPath
Location: Plymouth
Posted on: 01/19/2020

Travel Cardiovascular Intensive Care Unit Nurse (CVICU RN), Carmichael, CA
Description: Travel Cardiovascular Intensive Care Unit Nurse CVICU RN Carmichael, CALocation: Carmichael, CAStart Date: 2/4/2020Shift Details: 12H Nights 7:00 PM-7:00 AM 36 hours
Company: Triage Staffing
Location: East Providence
Posted on: 01/19/2020

RN, Oncology
Description: Concentric Healthcare Staffing has a new Travel--
Company: Concentric Healthcare Staffing
Location: Methuen
Posted on: 01/19/2020

Travel Pediatrics Intensive Care Unit Nurse (PICU RN), Northridge, CA
Description: Travel Pediatrics Intensive Care Unit Nurse PICU RN Northridge, CALocation: Northridge, CAStart Date: 2/10/2020Shift Details: 12H Nights 7:00 PM-7:00 AM 36 hours per
Company: Triage Staffing
Location: East Providence
Posted on: 01/19/2020

Medical Secretary-Pulmonary
Description: PRINCIPAL DUTIES AND RESPONSIBILITIES: ul li Follow established Brown Medicine EMR workflow protocols to maximize site's productivity and office flow efficiency. li Greet patients and visitors promptly. (more...)
Company: University Medicine
Location: East Providence
Posted on: 01/19/2020

Therapist / Physical Therapist Job in Peabody, Massachusetts / Skilled
Description: PT for Peabody, MA. SNF setting. br Experienced Physical Therapist treating patients with various conditions this will provide you with a wide range of expertise and career development.
Company: MAS Medical Staffing
Location: Peabody
Posted on: 01/19/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Peabody RSS job feeds