TUV Rheinland of North America
Medical Auditor Lead
TUV Rheinland of North America, Boxborough, Massachusetts, us, 01719
Joining TÜV Rheinland means working for one of the world’s leading testing, inspection, and certification service providers with more than 20,000 employees globally. Our employees are our most important asset. That is why we invest in their development and offer competitive pay, multiple health insurance plan options, and a 401(k) with up to 6% company match. At the same time we live an international, team-oriented culture characterized by respect, collegiality and openness. This enables our employees to develop their potential, apply new knowledge and methods directly - and plan a long-term career with real opportunities for advancement.
SUMMARYThe Auditor Lead position is responsible for evaluating clients' medical device management systems against international standards and regulations, leveraging their expertise in medical devices and related technologies. They work independently and as part of a team and may also serve as Product Specialists. The role involves a combination of auditing and technical documentation reviews, depending on their background.
PRINCIPAL DUTIES AND RESPONSIBILITIES
:
Plan, perform and document certification audits, surveillance audits, re-certification and unannounced audits a following relevant published standard(s), regulatory requirements, and company procedures, such as ISO 13485, MDSAP, EU MDD, EU MDR, EU IVDD, EU IVDR, and UK MDR
Lead audit team and be responsible for successful accomplishment of assigned project
Write, submit, and correct audit reports, client responses to audit nonconformities, and other technical documentation reports
Inform management through verbal and written communication of compliance issues, relevant standards, and regulatory requirements
Evaluate product non-conformance related to product processes and specifications
Evaluate and support vigilance cases as assigned
Establish and maintain strong professional relationships with customers
Maintain and expand technical expertise in specific product fields
Support colleagues with training, workshops and sharing or knowledge, as required
Perform other duties as assigned
QUALIFICATIONS & REQUIREMENTS:Knowledge, Skill, & Abilities
Broad knowledge of domestic and international regulatory compliance laws and regulations, including specific product directives
Ability to read and interpret documentation for compliance with procedures, standards, and regulations.
Ability to communicate with client’s highly specialized scientists, engineering, quality, technical and regulatory employees.
Must be highly organized and able to work independently.
Technical expertise in product field with relevant practical experience in the field of healthcare products, such as medical device or pharmaceutical industry, science, laboratories, notified bodies, examination centers or facilities that assess or manufacture medical devices.
Ability to travel domestically and internationally.
Valid passport and driver’s license required.
Education
Bachelor’s Degree in an Engineering, Physics, Computer Science, Materials Science, or a Life Science (Biology, Chemistry, Medicine, and Pharmacy) or equivalent education and/or experience
Masters or PhD desirable
Experience
2+ years of experience working with individual medical device products.
4+ years full-time work with relevant practical experience in the field of healthcare products, such as medical device or pharmaceutical industry, science, laboratories, notified bodies, examination centers or facilities that assess or manufacture medical devices.
Computer literacy required including Microsoft Office applications.
Certifications
Auditor certification desirable (ASQ, IRCA, Exemplar Global)
PHYSICAL DEMANDS & WORK ENVIRONMENT
Will work in an office environment from home, work office location, or client location(s)
Physical Activities for this position will Constantly include: Communicating with others to exchange information; Assessing the accuracy, neatness and thoroughness of the work assigned; and will Occasionally include: Ascending or descending ladders, stairs, scaffolding, ramps, poles and the like; Moving self in different positions to accomplish tasks in various environments including tight and confined spaces; Remaining in a stationary position, often standing or sitting for prolonged periods; Repeating motions that may include the wrists, hands and/or fingers; Operating motor vehicles or heavy equipment.
Environmental Conditions for this position will Occasionally include: Low temperatures; High temperatures; Outdoor elements such as precipitation and wind; Noisy environments; Hazardous conditions; Poor ventilation; Small and / or enclosed spaces.
Physical Demands for this position will Constantly include: Sedentary work that primarily involves sitting/standing; and will Occasionally include Physical effort may require lifting to up to 10 pounds.
Equipment Used
Laptop or Desktop Computer
Phone / Cell Phone or Headset
Travel Required
Ability to travel up to up to 75% may be required for this position.
TUV Rheinland North America EEO Statement
As a global business, TUV Rheinland North America relies on diversity of culture and thought to deliver on our goal of Creative People, Practical solutions serving our client needs, and ensures nondiscrimination in all programs and activities in accordance with Title VI and VII of the Civil rights Act of 1964. We continuously seek talented, qualified employees in our world-wide operations regardless of race, color, sex/gender, including gender identity and expression, sexual orientation, pregnancy, national origin, religion, disability, age, marital status, citizen status, protected veteran status, or any other protected classification under country or local law. TUV Rheinland North America is proud to be an Equal Employment Opportunity/ Affirmative Action Employer/ Federal Contractor desiring priority referrals of all protected veterans for job openings.
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SUMMARYThe Auditor Lead position is responsible for evaluating clients' medical device management systems against international standards and regulations, leveraging their expertise in medical devices and related technologies. They work independently and as part of a team and may also serve as Product Specialists. The role involves a combination of auditing and technical documentation reviews, depending on their background.
PRINCIPAL DUTIES AND RESPONSIBILITIES
:
Plan, perform and document certification audits, surveillance audits, re-certification and unannounced audits a following relevant published standard(s), regulatory requirements, and company procedures, such as ISO 13485, MDSAP, EU MDD, EU MDR, EU IVDD, EU IVDR, and UK MDR
Lead audit team and be responsible for successful accomplishment of assigned project
Write, submit, and correct audit reports, client responses to audit nonconformities, and other technical documentation reports
Inform management through verbal and written communication of compliance issues, relevant standards, and regulatory requirements
Evaluate product non-conformance related to product processes and specifications
Evaluate and support vigilance cases as assigned
Establish and maintain strong professional relationships with customers
Maintain and expand technical expertise in specific product fields
Support colleagues with training, workshops and sharing or knowledge, as required
Perform other duties as assigned
QUALIFICATIONS & REQUIREMENTS:Knowledge, Skill, & Abilities
Broad knowledge of domestic and international regulatory compliance laws and regulations, including specific product directives
Ability to read and interpret documentation for compliance with procedures, standards, and regulations.
Ability to communicate with client’s highly specialized scientists, engineering, quality, technical and regulatory employees.
Must be highly organized and able to work independently.
Technical expertise in product field with relevant practical experience in the field of healthcare products, such as medical device or pharmaceutical industry, science, laboratories, notified bodies, examination centers or facilities that assess or manufacture medical devices.
Ability to travel domestically and internationally.
Valid passport and driver’s license required.
Education
Bachelor’s Degree in an Engineering, Physics, Computer Science, Materials Science, or a Life Science (Biology, Chemistry, Medicine, and Pharmacy) or equivalent education and/or experience
Masters or PhD desirable
Experience
2+ years of experience working with individual medical device products.
4+ years full-time work with relevant practical experience in the field of healthcare products, such as medical device or pharmaceutical industry, science, laboratories, notified bodies, examination centers or facilities that assess or manufacture medical devices.
Computer literacy required including Microsoft Office applications.
Certifications
Auditor certification desirable (ASQ, IRCA, Exemplar Global)
PHYSICAL DEMANDS & WORK ENVIRONMENT
Will work in an office environment from home, work office location, or client location(s)
Physical Activities for this position will Constantly include: Communicating with others to exchange information; Assessing the accuracy, neatness and thoroughness of the work assigned; and will Occasionally include: Ascending or descending ladders, stairs, scaffolding, ramps, poles and the like; Moving self in different positions to accomplish tasks in various environments including tight and confined spaces; Remaining in a stationary position, often standing or sitting for prolonged periods; Repeating motions that may include the wrists, hands and/or fingers; Operating motor vehicles or heavy equipment.
Environmental Conditions for this position will Occasionally include: Low temperatures; High temperatures; Outdoor elements such as precipitation and wind; Noisy environments; Hazardous conditions; Poor ventilation; Small and / or enclosed spaces.
Physical Demands for this position will Constantly include: Sedentary work that primarily involves sitting/standing; and will Occasionally include Physical effort may require lifting to up to 10 pounds.
Equipment Used
Laptop or Desktop Computer
Phone / Cell Phone or Headset
Travel Required
Ability to travel up to up to 75% may be required for this position.
TUV Rheinland North America EEO Statement
As a global business, TUV Rheinland North America relies on diversity of culture and thought to deliver on our goal of Creative People, Practical solutions serving our client needs, and ensures nondiscrimination in all programs and activities in accordance with Title VI and VII of the Civil rights Act of 1964. We continuously seek talented, qualified employees in our world-wide operations regardless of race, color, sex/gender, including gender identity and expression, sexual orientation, pregnancy, national origin, religion, disability, age, marital status, citizen status, protected veteran status, or any other protected classification under country or local law. TUV Rheinland North America is proud to be an Equal Employment Opportunity/ Affirmative Action Employer/ Federal Contractor desiring priority referrals of all protected veterans for job openings.
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