Job Description

Position Title:  Quality Compliance Engineer

Pay:  $25.00 - $28.00/hour

Position Summary:  Provide engineering and technical support to Quality Compliance.  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 Company Quality System documents).  Provide support to other departmental activities as directed.

Essential Duties and Responsibilities:

• 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.
• Perform, with minimal supervision, those tasks required to successfully complete assigned projects.
• Bring to the attention of their immediate supervisor or the Director of Quality any incident that could negatively impact corporate goals and /or regulatory compliance requirements.

Requirements: 

• 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.
• Familiar with European Medical Device Regulation (MDR), ISO 13485:2016 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other 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.