Quality Risk Management Project Manager

Location: Virginia Beach, VA, Plainfield Indiana

Department: Quality Admin

Job Type: Full-Time

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

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, 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 provisions of organs, tissues and cells for transplantation; to provide innovation in the field 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 Risk Management Project Manager supports the compliance of the quality system to regulatory requirements and applicable standards specifically ISO 14971 current version. Responsible for providing compliant and pragmatic processes, reports, and solutions to support the Quality Engineering, Product Risk Management, and Post Market Surveillance activities. Supports risk management file content completion, integrity, and regulatory & standards compliance while collaboratively communicating & resolving gaps to achieve goals.

What you’ll do:

• Post-Market Surveillance: Defines and manages KPIs used to measure performance related to Product Risk Management processes. Executes and delivers on-time completion of the Risk Management Deliverables as related to the Post-Market Surveillance process. Provides review and approvals, and as necessary authoring of Risk Management deliverables such as reports, plans, matrixes, and summaries. Perform complaint investigations, root cause analysis, CAPA, and other QMS activities related to risk management and post-market surveillance activities. Performs updated post market surveillance reporting activities for each product family. Ensures risk control measures, reliability targets, and key safety and compliance requirements are incorporated into the risk management planning process. Leads risk management file updates in response to post market data.
• Risk Management File Maintenance: Supports the development process to ensure compliance of requirements and linkage to risk management file. Assures and maintains traceability among hazards, risks, risk analyses, evaluations and risk controls. Builds and maintains Risk Management Files for products. Determines if new or revised Risk Management documentation is required on an ongoing, but at least annual basis for each product family and update as appropriate.
• Process Establishment: Ensures that Quality System processes, specifically around Product Risk Management, are established, implemented, and maintained, and are in adherence with applicable regulations and standards, specifically ISO 14971. Develops, updates, and monitors risk management SOPs, work instructions and templates. Monitors and supports on-time completion of Risk Management Deliverables as related to Design Control processes. Supports the cross-functional product development teams in performing risk management activities including the management of risk management file (risk management plan/report, hazard analysis, FMEA). Supports processes for change controls for design changes during development and commercialization by assisting in identifying new risks associated with any changes. Participates in process improvement initiatives as necessary, performing gap analysis and risk communication. Establishes and maintains program milestones and timelines for risk management deliverables.
• Interdepartmental Interaction and Training: Establishes and maintains relationships with internal stakeholders to ensure that requirements for the Risk Management program and processes are understood and are achieved. Supports various sites when preparing for internal/external inspections specifically related to risk management activities. Establishes and provides risk management training requirements. Provides mentorship, guidance, and training to the Product Development teams, Quality Engineers, and P&L Engineers new to design controls and risk management processes. Works closely with various, involved departments to improve the link between development and production product risk management and the link with the Post-Market Surveillance process.
• Electronic Quality Management System: Supports the implementation of eQMS tools for Risk Management. Serves as the Risk Management reviewer designee for change control requests submitted through the eQMS tool.

What you’ll bring (Minimum Requirements):

• Bachelor’s degree
• 5 years’ experience in Quality related activities in an FDA regulated environment including tissue banking, medical device, or related industry.
• 2 years' project management experience

Preferred Qualifications:

• Bachelor's degree in Life Sciences or related; Master's Degree in Life Science
• BSI Lead auditor certification
• LEAN Green or Black Belt certification
• Certified Tissue Banking Specialist (CTBS) or obtain within one year of employment
• 5 years' experience in product risk management, specifically ISO 14971 requirements
• 2 years’ experience with LEAN manufacturing concepts and tools
• 2 years' Product and/or Process Development experience in a related industry
• 1 year Quality Assurance or Records Management experience or experience handling Product Development or Design History File records

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

• Industry regulations, standards, and guidelines - Experience reviewing requirements, determine relevance to processes within the organization, and ensure compliance as applicable
• Relationship Management - Builds and sustains partnerships across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes
• Communication skills - Written, verbal and presentation; ability to engage, inspire and influence people
• Analytical Thinking - Demonstrates the ability to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends
• Organizational Skills - Ability to plan, implement and monitor assignments effectively to meet the needs of the business
• Time Management - Ability to use time in an effective and productive manner with ability to work under pressure with tight timelines, make critical decision and maintain a sense of focus and urgency
• Problem Resolution - Ability to anticipate and critically think through problems
• Project Management - Ability to communicate and plan projects, negotiate, and resolve conflict, and build commitment with the team. May include ability to influence without authority.
• Technical Writing - Able to create and revise procedures, technical documents, and other relevant material according to established requirements
• Microsoft Office - Proficient in Microsoft Office; Demonstrated knowledge of spreadsheet and database applications usage

Preferred Knowledge & Skills:

• Knowledge with applicable tissue banking/medical device related regulations, standards, and guidelines 21 CFR 1271, 21 CFR 820, ISO 13485 and 14971, AATB Standards
• Adobe Pro and DocuSign
• Engineering - Understanding of basic engineering concepts

Why work at LifeNet Health?

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

• 403(b) and Profit Sharing
• Medical, dental, and vision coverage
• Work-life balance with generous paid time off
• Tuition reimbursement
• Personal career and skill development opportunities
• Wellness Program
• Employee Assistance Program (EAP)
• Dedicated and passionate co-workers

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.

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