Job Category: Technical assessments & Auditing
Location: Work from Anywhere (Remote/ Home -Based)
To be discussed.
Intertek’s comprehensive range of auditing and certification services ensure that management systems are optimized to facilitate successful growth. Our global network of auditors and technical experts are dedicated to helping our clients meet any auditing or certification challenge they may face. From sharing best practices and new industry requirements, to assessing performance against objectives, our team gives our clients the means to evaluate and enhance their business while meeting both external and internal customer expectations.
This role has accountability to support the operation of the business by providing assessments and reviews of client’s compliance to the appropriate EU Regulatory requirements for Technical Documentation in a timely and accurate manner, in accordance with the documented procedures and forms under the relevant Intertek, Notified Body Designation and AB requirements. The position is a home-based role and may involve travel throughout the US and internationally to client’s facilities to execute assessments or act as a Technical Expert in an audit team.
The role holder is expected to deliver Technical assessments as follows:
- Assessment of EC Technical Documentation.
- Act as a Technical Expert in an audit team.
- Perform independent reviews of above Technical Documentation assessments.
- Document the above assessments in accordance with the appropriate current local and global Intertek issued processes, and complete them within the allocated times as they are allocated to them.
- Keep up to date with the appropriate regulatory requirements, guidance, and changes in standards relating to the NBOG codes that have been allocated to them.
- Audits are required to take place at the client’s facility. Therefore if acting as a Technical Expert in a team, some travel will be required.
- Comply with the relevant Quality System processes and procedures at all times.
- May be required to develop materials and deliver training courses, and attend seminars and conferences.
- May also be required to undertake reasonable “unspecified duties” in support of Notified Body operations from time to time.
- Interact on a frequent basis with the following internal and external personnel in the execution of their duties, including clients, assessors and reviewers, operations staff, external agencies (e.g. MHRA, UKAS, Health Canada, SCC) and management.
- A degree, preferably an advanced degree, in either Health Science, Engineering, or Quality/Regulatory disciplines related to the Medical Device or Pharma industry sectors, or equivalent relevant education
- Experience with medical device regulation and standards, including the EU Medical Device Directive
A minimum of 5 years of full-time work experience in medical device related industry, including registrar.
- Preferably at least 3 years of experience working in a Health Science related industry in Design, manufacturing, or
- Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or testing laboratories
- In-depth knowledge of medical device QMS certification process, including contracting, scheduling, auditing, and post-audit activities.
- Strong and clear communication and interpersonal skills.
- Sound judgment, organization, and analytical skills.
- Excellent computer and writing skills.
- Ability to coordinate between parties, including customers and other company functions.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to exercise effective time management skills in completion of assignments.
- Must be willing and able for domestic travel. International travel may be needed (requires passport).
- Intertek offers a salary and benefit package competitively placed within the local market. We promote a culture where motivated, customer-oriented employees can flourish, experience professional fulfillment, and reach their highest potential. We offer medical, prescription, dental, vision, life and disability insurance plans, 401(k) with company match, paid time off (vacation, sick, holiday), Flexible Spending Account (FSA), Employee Assistance Program (EAP), tuition reimbursement, and more.
- We are an Equal Opportunity Employer and do not discriminate against applicants due to veterans status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.
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