ABOUT THIS JOB
Location: Concert Drive, Virginia Beach, VA

Department: Quality Engineering

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

Clinical Status: Clinical

HOW YOU'LL MAKE AN IMPACT
As a Quality Engineer II, you'll play a vital role in advancing our mission. In this position, you'll 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 YOU'LL 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 YOU'LL BRING
Minimum 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 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:

• Master's 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.

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.