Associate degree required
Minimum 2+ years of experience in Quality Assurance, preferably in a supervisory role
Familiarity with ISO 9001 and quality management systems
Understanding of risk-based quality techniques and their impact on product fit, form, and function
Strong analytical, organizational, and problem-solving skills
Excellent communication skills with the ability to work independently and in team settings
Experience working with cross-functional teams to resolve quality issues
Authorize product release and enforce established quality standards
Develop and manage incoming material inspection processes
Establish QC procedures, inspection criteria, and controlled documentation
Lead, mentor, and train QA/QC team members, including resource planning
Maintain audit readiness and represent Quality during internal and customer audits
Oversee non-conformance investigations and ensure effective CAPA implementation
Monitor cleanroom bioburden and particulate levels, escalating deviations as needed
Track and report QC metrics, inspection results, and trend analysis
Collaborate cross-functionally with manufacturing, engineering, logistics, and supply chain
Perform additional duties as assigned

FM Approvals Engineering Quality Auditor II

Norwood, MA 02062

Bachelor's Degree in one of the following disciplines: Electrical, Mechanical, Chemical, Industrial Engineering or a science-based equivalent degree
5+ years of manufacturing process experience
5+ years of related quality assurance and quality auditing experience
Valid driver's license required
Tenured audit experience with demonstrated proficiency performing conformity assessment audits
Ability to obtain and assess objective evidence throughout the audit process while acting impartially and maintaining confidentiality
Observe, document, and evaluate audit observations while effectively managing customer interactions throughout the audit process
Experience with various measurement tools such as pressure gauges, calipers, voltmeters, etc.
Computer literacy with demonstrated proficiency in Microsoft Office Suite
Ability to read and interpret engineering technical drawings
The role requires approximately 70% travel, and 30% travel may require overnight stays