Quality Engineer

Quality Engineer

Location: Virginia Beach, VA (on-site)

Department: Quality Engineering

Job Type: Full-Time

Shift: 8:15 a.m.- 5:00 p.m. (ET), Monday – Friday, Up to 20% travel

Clinical Classification: Clinical

LifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope.

LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization (“OPO”) and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine. Our goal is to improve the quality of human life through the provision of organs, tissues and cells for transplantation; to provide innovation in the fields of bio-implants, regenerative medicine and research; and, to serve the community with educational and support services that enhance the donation process.  LifeNet Health has over 1200 employees and has a growing global presence.

How you will contribute to LifeNet Health’s success:

The Quality Engineer plays a key role in the Quality Systems and Regulatory Compliance teams through ensuring compliance of products with all applicable federal, industry, and company procedures, guidelines, and regulations during the development, receipt, storage, manufacture, and distribution of products. The Quality Engineer role serves as an internal consultant and is responsible for risk mitigation through various processes e.g. Employee Safety, Supplier Quality, and Risk Management processes. This role ensures that the introduction of new products into production is compliant with GTP, GMP, ISO, and OSHA requirements. Participates on cross-functional teams to evaluate new products, including medical devices, for compliance with the Quality Management System and regulating bodies.

What you’ll do:

• Design Control and Production: Provides quality engineering support to new product development teams in the design control process. Provides quality and reliability engineering support to value streams including approving protocols for various process and product qualification studies e.g. IQ, OQ, PQ. Ensure executable protocols comply with applicable federal, industry, and company procedures, guidelines, and regulations. Serve as a member of the Design Control Review Team. Provides quality engineering support on root cause analysis and problem solving for Operations groups as needed.
• Risk Management: Ensure compliance with ISO 13485 and ISO 14971. Leads risk management activities during Design Control and post-production activities. Reviews and provides data analysis for complaints and nonconformance issues related to post-production activities. Maintains the risk management file for products, including medical devices. Collaborates with design control teams in developing and executing design risk analyses, risk management plans, dFMEA, pFMEA, hazard traceability matrix, risk management rile reviews during design control, risk benefit analysis, risk management report, authors period safety report updates (PSURs) and pharmacovigilance reports for competent authorities. Performs risk assessment as part of post-market monitoring in support of complaint risk analysis, field corrective actions, design changes, product life cycle sustaining efforts, and others. Supports MDSAP audit.
• Supplier Quality Program: Effectively executes the Supplier Quality program including on-site,
• desktop, virtual, and other Supplier Quality Audits. Manages supplier audits and agency communication with suppliers. Conducts effective execution of the supplier selection and approval process. Initiates, measures, and communicates supplier performance on key metrics and the corresponding continuous improvement plans/audit findings. Has oversight for the needed improvement action throughout the supply chain. Responsible for maintenance of supplier FMEA and supplier audit selection and prioritization. Generates quality master agreements when appropriate. Provides expertise and approval on supply non-conformities or alternate supply selection.
• Non-conforming Review Board: Conducts NCRB review for non-conforming supplies received and determines appropriate disposition of supplies. Performs NCRB review for tissue related items requiring cross-functional team review and approval. Determines disposition of medical devices and products related to non-conforming issues.
• Employee Safety: Leads Corporate Employee Safety Program including leading large cross- functional teams for successful execution of Safety Program including ensuring corporate compliance with applicable OSHA regulations and company policies. Acts as the corporate safety officer. Conducts quarterly employee safety meetings. Report required incidents to the appropriate regulatory bodies, including OSHA.
• Equipment: Ensures equipment validations meet applicable federal, industry, and company procedures, guidelines, and regulations. Reviews equipment related non-conformance or out of tolerance issues for approval or proper disposition, as needed and required.

What you’ll bring (Minimum Requirements):

• Bachelor's Degree in Engineering or similar technical/science degree
• Auditor Training by a reputable organization (such as BSI, AIAG, etc.) - Current or to obtain within six months of employment
• Two (2) years of Quality Engineer or related Medical Device experience

Preferred Experience/Skills/Certifications:

• Master’s Degree in Engineering or similar technical/science degree
• Auditor training by American Society for Quality (ASQ)
• Certified Quality Engineer (CQE)
• Two (2) years of Supplier Management experience
• Two (2) years of Project Management experience
• Two (2) years of experience with LifeNet Health, preferably in an Engineering role.
• One (1) year of Risk Management experience
• One (1) year of Employee Health & Safety experience
• OSHA Regulations: Knowledge of state and federal regulations
• CAPA Process: Root cause investigation and determination and corrective and preventive actions
• LEAN/Six Sigma: 8D method of problem resolution. Quality issues correction and prevent recurrence. Knowledge and experience of choosing KPls in Safety, Quality, Delivery, Productivity and Cost areas

 These would be nice too (Knowledge Skills and Abilities):

• Proficient in Microsoft Office: PowerPoint, Excel, Word, Outlook, Microsoft Suite.
• Time Management: Ability to prioritize multiple, competing priorities and manage time/workload. Demonstrated ability to effectively prioritize and juggle multiple time sensitive projects, multi-task, identify project interdependencies and potential risks/pitfalls.
• Attention to Detail: Ability to perform tasks thoroughly and with care; checks work to ensure high degree of accuracy/completeness and early/on-time delivery.
• Communication skills: Excellent verbal and written communication skills; ability to communicate and build relationships with all professionals at different levels within the organization.
• Teamwork: Ability to be collaborative and work as part of a team to resolve issues, complete tasks and meet business needs.

Why work at LifeNet Health?

We have a fierce drive for our mission of Saving Lives, Restoring Health, and Giving Hope. You will not find another company with a culture as strong as ours.

• 403(b) and Profit-Sharing Plan
• Affordable medical, dental, and vision coverage
• Corporate sponsored events for employees
• Work-life balance with generous paid time off to include vacation time, sick time, and paid holidays
  • 18 vacation days
  • 9 sick days
  • 7 paid holidays
• Tuition reimbursement
• Personal career, skill, and leadership development opportunities
• Wellness Program (gym reimbursement, monthly wellness webinars, mental health toolkit, financial resources, and much more)
• Employee Assistance Program (EAP) for employees and members of their household
• Dedicated and passionate co-workers

Salary: $65,972- $87,962 annually

The pay rate for the successful candidate will depend on geographic location and the candidate’s qualifications and prior relevant experience. The pay range for this position is $65,972 annually (entry-level qualifications) to $87,962 annually (experienced in this role).

* Actual compensation may be higher based on the successful candidate’s knowledge and relevant experience.

This position is eligible for an annual bonus once eligibility criteria are met. 

All benefits are subject to eligibility requirements and LifeNet Health reserves the right to modify or change these benefits programs at any time, with or without notice, unless otherwise required by law. Further, nothing in this posting is intended to alter the “at will” relationship of a successful candidate and this posting does not constitute a specific promise.

We are proud to be an EEO/AA employer EOE/M/F/Disability/Vet. We maintain a drug-free workplace and perform pre-employment substance abuse testing.