The primary purpose of this job is to manage engineering functions. Identify and evaluate procedures and process equipment required to produce a quality product.
- Do you have a passion for quality systems?
- Are you looking to join one of the top medical device quality organizations?
- Are you a natural problem solver?
If you answered yes, we'd love to speak with you. Integer is hiring for a Senior Quality Systems Engineer.
Accountabilities & Responsibilities:
- Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Leads the execution and improvement of quality assurance and quality systems activities.
- Develops and manages quality systems that comply with national and global regulatory requirements.
- May lead and conduct detailed quality analyses including cost of quality trends and root cause analyses.
- Develops new and unique approaches to complex problems and advance technology beyond previous company involvement.
- Plans/develops engineering projects concerned with unique or high-profile problems which have important effect on major organization programs.
- Provides management with technical guidance as required.
- Identifies and procures the appropriate process equipment.
- Investigates, develops and implements new process technologies of major scope.
- Maintains liaison with individuals and business units within or outside his/her organization with responsibility for acting independently on technical matters pertaining to his/her field.
- Subject matter expert in engineering specialty/application.
- Performs other duties as required.
Minimum Education & Experience:
- Bachelor's degree required (technical discipline preferred)
- 7+ years Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or Diagnostics industry
- Specialized Knowledge: Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485). Problem Solving and training skills.
- Special Skills: Proficient in Microsoft Office applications required. Familiarity with eQMS Programs (TrackWise, EtQ, etc.) desired.