Title: Quality Compliance Associate
Pay: $22.00 - $23.00/hour
Position Summary: Perform activities for preparation of European Medical Device Regulations (MDR). Evaluate the operation of Manufacturing and Quality activities in relation to Compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated (e.g. performing Gap Assessments with new or updated Standards or Regulations to Quality System documents). Provide engineering and technical support to Quality Compliance. Participate in internal and external audits/ inspections. Provide support to other departmental activities as directed.
Essential Duties and Responsibilities:
- Assist with internal and external audits, and potential audit findings.
- Assist with State license renewals/accuracy.
- Work within Company Quality System.
- Assist with continued company certification to the appropriate Quality System Standards and Regulations, and assist with all related inspections as required.
- Generate, review and approve internal operating procedures and specifications.
- Coordinate/Support the operation of Internal and Supplier Audit Systems. Provide leadership as required while conducting all such audits.
- Assist with adherence to all Federal, State and Local Regulations controlling the manufacture and distribution of medical devices and accessories, pharmaceuticals, cosmetics and Over the Counter (OTC).
- Assist with training to all company employees as required.
- Provide support within the Quality department and to other departments as directed by Quality Management.
- BS in a Physical Science or Engineering, or equivalent experience required.
- Minimum 2-4 years Quality Assurance and/or other regulated industry or similar experience required.
- Strong Technical writing and general problem –solving skills required.
Additional Preferred Experience:
- European Medical Device Regulation (MDR).
- ISO 13485:2016 Quality System Standards.
- FDA Quality System Regulations.
- Current GxP.
- International medical device regulations.
- Preferred experience in performing internal and/or supplier audits.
- Proficient in MS Word, Excel and PowerPoint software programs.
- ASQ Certification as a Quality Auditor, Quality Engineer or equivalent desirable.