The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance
Job Summary
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
The company fosters a culture that unifies, embraces uniqueness, and positions for long-term success through core values like Customer focus, Innovation, Collaboration, Inclusion, Candor, and Integrity.
The total rewards program includes base salary, cash-based incentive program, comprehensive benefits with immediate eligibility, parental leave, and 401(k) plan with company matching contributions.
Matching Summary
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
Salary
Base: $77,570 - $113,740; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with match, 80 hours holidays, paid time off
Skills & Requirements
Must-have
Quality System requirements adherence
Regulatory and Standards compliance
Device History Records maintenance
Test method validation protocols
Non-conforming material disposition
CAPA activities participation
Nice-to-have
Work independently and in team
Effective written and verbal communication
Time management skills
Continuous improvement project participation
Key Requirements
Bachelor’s Degree in Engineering
2-5 years quality engineering experience
Medical device or regulated manufacturing experience
Competence in Quality Engineering Tools
Knowledge of Domestic and International Regulations