Quality Engineer II (10135-2026532)

About the role

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. This job is located at Concert Drive, Virginia Beach, VA in the Quality Engineering department. The schedule is Monday-Friday from 8:15 AM to 5:00 PM. The clinical status is Clinical.

Responsibilities

• Lead 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.
• Ensure 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.
• 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.
• Lead and support continuous improvement efforts including enhancing testing processes, methodologies, and tools.
• Drive strategic initiatives to enhance quality system robustness.
• Support post-market activities, including complaint investigation, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
• Lead and facilitate 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.
• Oversee and approve quality risk assessments for product and process changes; ensure product quality and compliance with appropriate change controls and implementation.
• Support regulatory inspections and external audits related to production activities.
• Collaborate with regulatory affairs to ensure that product submissions meet regulatory requirements.

Requirements

• Bachelor’s Degree – Engineering
• FIVE (5) Years with Bachelor’s Degree OR THREE (3) Years with Master’s Degree/PHD – Experience in Production/Design Control processes, v&v activities, risk management, corrective and preventive 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

• Master’s Degree or PhD – Engineering
• Experience in medical devices or similar regulated industry
• Auditor training by American Society for Quality
• Certified Quality Engineer
• Lever 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
• 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
• 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

Benefits

• Compensation: Salary Range: $87,226 - $116,301
• 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 candidate’s 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.