Bachelor's Degree in engineering or equivalent experience
10+ years in medical device manufacturing
Expertise in quality systems per 21 CFR 820 and ISO 13485
Deep knowledge of GMP and GDP
Understanding of ISO 14971 and risk management
Proven leadership in quality assurance
Strong communication skills across disciplines
Experience with quality tools and methodologies
Familiarity with statistical software like Minitab
Proficient in Product Lifecycle Management software
Intermediate to advanced MS Office skills
Responsibilities
Support US manufacturing and assist global sites up to 10%
Contribute to product development deliverables as a core team member
Draft and approve project deliverables and engineering work orders
Coordinate process output testing for verification and validation
Maintain up-to-date Device Master Records (DMR)
Analyze and present product-specific Quality metrics
Lead manufacturing/DHR review during complaint investigations
Promote Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
Identify and improve Quality System requirements
Manage nonconformance investigations and corrective actions
Serve as Subject Matter Expert for audits
Lead Product Lifecycle Management architecture changes
Benefits
Health Care Plan (Medical, Dental & Vision)
Retirement Plan with Company Match
Paid Time Off, Personal Days, AND Birthday Holiday!
Lifetime Membership Subsidy and Wellness Resources
Life Insurance (Basic, Voluntary & AD&D)
Family Leave (Maternity, Paternity)
Short-Term & Long-Term Disability
Taco Thursdays!!!
Full Job Description
Please note - No sponsorship or transfer of sponsorship is available for this role, including but not limited to OPT and H-1B
This role is responsible for manufacturing and device quality for commercial devices and manufacturing transfers. Quality engineers own sustaining activities for investigational and commercial device manufacturing, such as changes, audits, nonconformances, CAPAs, and complaint investigations ensuring timely completion of activities. All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.
RESPONSIBILITIES
Primarily supports US manufacturing, but may support global manufacturing sites up to 10%
Phase 4-5 Project core team member accountable for product development deliverables including, but not limited to: Process risk assessment (PFMEA); Master Validation Plan(s) and Report(s); Failure/Scrap code identification and maintenance in alignment with process risks; Manufacturing, process monitoring, and product acceptance plans
Draft, collaborate, and approve project deliverables and engineering work orders
Coordinate and execute, as necessary, process output testing (verification/validation)
Create and maintain up-to-date product Device Master Records (DMR)
Compile, analyze, and present product specific Quality metrics for various review forums
Own manufacturing/DHR review as part of complaint investigations
Lead by example in Good Manufacturing Practices (GMP) and Good Documentation Practices (GMP)
Proactively identify redundancy and opportunities for improvement in Quality System requirements
Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are properly documented and executed
Identify, own, and execute nonconformance investigations and implementation of corrective and preventive actions, as necessary
Support audits as Subject Matter Expert (SME) for QMS processes and product line manufacturing
Lead Product Lifecycle Management (PLM) architecture and changes, as needed
Requirements
QUALIFICATIONS
Required:
Bachelor's Degree (BS) in engineering discipline or equivalent combination of education and experience.
10+ years of experience in medical device manufacturing
Success working in quality systems as defined in 21 CFR 820 and ISO 13485.
Expert level knowledge and application of GMP, GDP
Intimate understanding of ISO 14971 and application of risk management principles
Demonstrated technical expertise and leadership in quality
High attention to detail, organization, and accuracy
Instinctual capability for creative thinking and proposing novel solutions
Strong ability to communicate (written and verbally) within and across disciplines and organization structures
Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc..)
Familiarity with common statistical software, such as Minitab
