Quality Engineer II

AT LIFENET HEALTH YOU ARE THE ADVANTAGE

Every day YOU help us to save lives restore health and bring hope to patients and families around the world. At LifeNet Health we cultivate growth innovation and collaboration where your contributions drive solutions that benefit humanity.

Together we are united by a mission greater than ourselves a purpose rooted in healing.

ABOUT THIS JOB
Location: Concert Drive Virginia Beach VA

Department: Quality Engineering

Schedule: Monday-Friday 8:15AM 5:00PM

Clinical Status: Clinical

HOW YOULL MAKE AN IMPACT
As a Quality Engineer II youll play a vital role in advancing our this position youll be responsible for leading quality engineering for product development and sustaining engineering driving quality compliance risk management and continuous improvement in the medical device/biologics/tissue combination product industry. This role involves leading cross-functional initiatives and serving as the primary Quality Engineering representative in design and production efforts ensuring strategic alignment with regulatory and business objectives while partnering with cross-functional teams to ensure that production processes and outputs meet all applicable regulatory requirements including but not limited to FDA 21 CFR Part 820 21 CFR Part 1271 ISO 13485 and ISO 14971. This role will also play a critical role in risk management design verification and validation (V&V) production and continuous improvement initiatives.

Your work will have purpose every single day contributing directly to life-changing outcomes.

WHAT YOULL DO

Production / Design Core Function

Assigned to either Production or Design core functions within the Quality Engineering Department.

Production:

• Lead Engineer for ensuring compliance with regulatory requirements and company standards in all production activities.
• Serve as the lead Quality Engineering authority with Procurement Receiving and Business Units to meet component requirements and improve quality control inspection methods.
• Serve as the lead Quality Engineering authority for management of NCRs CAPAs Deviations and other Quality System elements.
• Manage nonconforming materials and ensure proper documentation and communication for resolution.
• Develop and implement quality control inspection plans and ensure First Article Inspections for new or modified articles are completed.
• Quality Engineering authority for Supplier Quality activities including selection evaluation and performance reviews while providing input on product and process development for manufacturability and compliance.

-or-

Design:

• Serve as the lead Quality Engineering authority across the product development lifecycle including design development reviews and post market activities and driving quality strategy in cross-functional team from concept through design transfer and commercialization.
• Ensure that all design control activities are conducted in compliance with regulatory requirements and company standards.
• Quality Engineering authority for design inputs design outputs design verification and validation plans/reports and design transfer activities.
• Quality Engineering authority in design reviews ensuring that design risks are identified assessed and mitigated appropriately.
• Quality Engineering authority on product and process development to ensure manufacturability reliability and compliance with quality standards.

Verification and Validation (V&V)

Ensures design verification and validation protocols and associated reports for products and production meet defined quality requirements and specifications

• Oversees R&D manufacturing processing design quality and other teams to ensure that V&V activities are conducted in compliance with regulatory requirements
• Quality Engineering authority for analytical methods processes and equipment to ensure that testing methods are accurate reliable and suitable for their intended purpose.
• Lead and supports continuous improvement efforts including enhancing testing processes methodologies and tools.
• Quality Engineering authority for V&V data to ensure that products are safe effective and meet customer and regulatory expectations.

Sustaining Engineering

Provides quality engineering leadership for sustaining engineering activities including product changes process improvements and design modifications.

• Oversee and approve quality risk assessments for product and process changes; ensure product quality and compliance with appropriate change controls and implementation
• Drives strategic initiates to enhance quality system robustness
• Support post-market activities including complaint investigation root cause analysis and implementation of corrective and preventive actions (CAPAs).

Risk Management

• Ensure that risk management activities are integrated into the production control process and are continuously monitored throughout the product lifecycle in accordance with ISO 14971.
• Leads and facilitates risk assessment for product and process design or changes to support the Process Failure Mode and Effects Analysis (PFMEA) and other risk assessment tools to identify potential risks and develop mitigation strategies.

Continuous Improvement

• Leads identification and implementation opportunities for continuous improvement in design quality processes and practices.
• Participate in cross-functional teams to drive quality improvements and operational efficiencies.
• Monitor and analyze quality metrics related to production activities and report findings to management.

Regulatory Compliance and Audits

• Support regulatory inspections and external audits related to production activities.
• Ensure that Product Master Record files (PMR) and technical documentation are complete accurate and compliant with applicable regulations.
• Collaborate with regulatory affairs to ensure that product submissions meet regulatory requirements.

WHAT YOULL BRING
Minimum Requirements:

• Bachelors Degree Engineering
• FIVE (5) Years with Bachelors Degree OR THREE (3) Years with Masters Degree/PHD Experience in Production/Design Control processes v&v activities risk management corrective and preventative action investigation and root cause analysis process flow charts FMEAs PFMAs purchasing controls and control plans
• Auditor Training current or obtained within 6 months of employment (BSI AIAG etc)

Preferred Experience/Skills/Certifications:

• Masters Degree or PhD Engineering
• Experience in medical devices or similar regulated industry
• Auditor training by American Society for Quality
• Certified Quality Engineer
• Lean Six Sigma Green Belt or higher
  

Key Knowledge Skills & Abilities:

• Communication Skills: Excellent verbal and written communication skills; ability to communicate and build relationships with all professionals at different levels within the organization
• 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 KPIs in Safety Quality Delivery Productivity and Cost Areas
• Proficient in MS Office: PowerPoint Excel Word Outlook Microsoft Suite as position requires
• Time Management: Able 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: Able to perform tasks thoroughly and with care; checks work to ensure high degree of accuracy/completeness and early/on-time delivery
• Teamwork: Ability to mentor junior staff and lead teams. Ability to be collaborative and work as part of a team to resolve issues complete tasks and meet business needs.

WHY JOIN LIFENET HEALTH

When you join LifeNet Health youre not just taking a job youre joining a mission-driven community dedicated to making a global impact through regenerative medicine. Youll be part of a workplace that values authenticity collaboration and the drive to make a difference.

We recognize that great work happens when people feel supported. Thats why our total rewards package is designed to help you thrive both professionally and personally.

Heres how we support YOU:

• Affordable Medical Dental and Vision Coverage- Comprehensive care that wont break the bank.
• Profit Sharing Plan- Share in the success you help create.
• 403(b) Retirement Plan- Invest in your future with confidence.
• Paid Parental Leave- 6 weeks to bond with your newest family member.
• Corporate Sponsored Events- Celebrate milestones and build connections.
• Generous Paid Time Off- Because balance matters:
  • 18 vacation days (based on position tenure and state laws)
  • 9 sick days (subject to local and state regulations)
  • 9 holidays (7 standard 2 floating)
• Flexible Work Program- For approved roles how and where you perform best.
• Tuition reimbursement- We invest in your growth and education.
• Career & Leadership Development- Expand your impact and potential.
• Wellness Program- Prioritize your health with holistic resources.
• Employee Assistance Program (EAP)- Support for you and your household.
• Incredible teammates- Collaborate with passionate dedicated professionals.
  

Note: All benefits are subject to eligibility requirements and may be modified at any time with or without notice unless otherwise required by law. This job posting does not constitute an employment contract and does not alter the at-will nature of employment at LifeNet Health.

COMPENSATION

Salary Range: $87226 - $116301

Final compensation will be based on factors such as geographic location qualifications and prior relevant experience. Actual compensation may be higher based on the successful candidates knowledge and relevant experience.

EQUAL OPPORTUNITY EMPLOYER

LifeNet Health is an equal opportunity employer. We consider all qualified applicants without regard to race color religion sex sexual orientation gender identity national origin disability veteran status or any other legally protected status.

As part of our commitment to safety we maintain a drug-free workplace and conduct pre-employment substance abuse screening.