Permanent position: Quality Systems Engineer needed in the Hudson, MA area for immediate consideration. The right person supports external quality audits and leads/supports internal quality audit teams to assure that site activities comply with all applicable regulatory requirements, policies and procedures. Must have a BS in Science, Health, or Engineering along with 5+ years of in FDA-regulated (i.e. medical device, IVD, pharma) along with experience working to interpret and apply quality regulations and standards. Apply now
Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- Maintaining internal process for continuous compliance with corporate / global quality system and external requirements
- Communication and documentation of internal and external compliance-related information including changes in external requirements, corporate requirements, and local changes to ensure continuous compliance
- Involved in handling audit non-conformances, evaluating impact to compliance, and facilitating sustainable fixes
- Advise management on potential improvements or enhancement to quality systems and processes in the company.
- BS in Science, Health, or Engineering
- 5+ years of in FDA-regulated (i.e. medical device, IVD, pharma) experience
- Experience working to interpret and apply quality regulations and standards.
- Previous accreditation as quality auditor (e.g. ASQ CQA, etc)