Please note - No sponsorship or transfer of sponsorship is available for this role, including but not limited to OPT and H-1B
At Nextern, we inspire with passion, impact with significance, and act with integrity. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.
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
- Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)
- Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook).
Preferred:
- Secondary certification in Quality (e.g. CQE, CQA) or lean (e.g. six sigma) principles preferred
Salary range: $130,000 to $170,000 based on skills and experience
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!!!
Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.