$77,570 - $113,740; not specified; comprehensive b...
Quality system requirements adherence
Medical device manufacturing compliance
Regulatory and standards compliance
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.
This role involves supporting regulatory and agency inspections, monitoring manufacturing, reviewing changes to product documentation, and leading test method validations.
The company offers a comprehensive total rewards program including base salary, incentive program, medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with matching, holidays, and paid time off.
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
$77,570 - $113,740; Not specified; Comprehensive benefits package
Skills & Requirements
Must-have
Quality System Requirements Adherence
Medical Device Manufacturing Compliance
Regulatory and Standards Compliance
Product Design and Manufacturing Quality Control
Non-conforming Material Disposition
Corrective Action Implementation
Nice-to-have
Team Collaboration and Communication
Continuous Improvement Project Participation
Mentoring Quality Inspectors and Technicians
Adaptability to New Product Transfers
Key Requirements
Bachelor's Degree in Engineering or related field
2-5 years quality engineering experience
Experience in medical device or regulated manufacturing
Proficiency in Microsoft Office and Minitab
Competence in Quality Engineering Tools and Techniques
Knowledge of Domestic and International Regulations and Industry Standards