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 I you'll play a vital role in advancing our mission. In this position, you'll be responsible for assisting 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 cross-functional initiatives and serving as the 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

Serve as the Quality Engineering authority supporting both product development and production lifecycle activities within the Quality Engineering Department.

• Serve as the Quality Engineering representative across the entire product lifecycle, including concept development, design controls, verification and validation, design transfer, commercialization, and sustaining engineering activities.
• Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities.
• Provide Quality Engineering leadership for design inputs/outputs, verification and validation protocols and reports, risk management activities, and design reviews, ensuring risks are identified, assessed, and mitigated appropriately.
• Support and approve NCRs, CAPAs, deviations, change controls, and nonconforming material investigations, ensuring effective root cause analysis and resolution.
• Develop and implement inspection strategies, control plans, and First Article Inspection requirements for new and modified components and processes.
• Partner with Procurement, Receiving, Manufacturing, and R&D to support supplier quality activities including qualification, evaluation, monitoring, and performance improvement.

• Provide quality engineering input into product and process development activities to ensure manufacturability, reliability, and compliance with internal and external requirements.

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.
• 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
• TWO (2) Years - Engineering experience or similar regulated industry (with a Bachelor's) OR Zero (0) years with a Master's Degree

Preferred Experience/Skills/Certifications:

• Master's Degree or PhD - Engineering
• Experience in medical devices or similar regulated industry

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
• 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: $75,841 - $101,121

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.