The role involves championing compliance with global regulations such as QSRs, ISO, and the Medical Device Directive while supporting internal and external audits
Job Summary
The role involves championing compliance with global regulations such as QSRs, ISO, and the Medical Device Directive while supporting internal and external audits.
Candidates will be accountable for material identification, segregation, defect classification, and the review of root cause investigations for non-conformances and customer complaints.
Employees are eligible for a comprehensive benefits package including vacation, sick time, parental leave, and participation in the company's long-term incentive program.
Matching Summary
The role involves championing compliance with global regulations such as QSRs, ISO, and the Medical Device Directive while supporting internal and external audits.
Salary
Base: $65,000.00 - $104,650.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Vacation, Sick time, Holiday pay, Parental Leave, Bereavement Leave
Skills & Requirements
Must-have
Bachelor's degree in Engineering or related field
0-2 years experience in Medical Devices industry
Knowledge of ISO 13485 and FDA QSR regulations
Experience with CAPAs, non-conformances, and audits
Strong root cause investigation and data analysis skills
Nice-to-have
Process Excellence or Six Sigma Certification
Good Automated Manufacturing Practice (GAMP) knowledge
Lean Supply Chain Management experience
Customer Centricity and Data Savvy traits
Ability to lead validation strategies
Key Requirements
Bachelors or equivalent university degree in Engineering
Minimum 0-2 years relevant professional work experience
Required knowledge of quality management systems and regulatory requirements