Quality Systems Engineer

Location: Plainfield, IN

Department: Quality Systems

Job Type: Full-Time

Shift: Mon. – Fri.: 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, Virginia, 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 provision of organs, tissues and cells for transplantation; to provide innovation in the fields 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:

Responsible for monitoring and enhancing the operational effectiveness and regulatory compliance of in-process inspections, final graft inspections, and returned graft inspections. Manages, monitors, and enhances the effectiveness of all aspects of product-related complaint investigations, nonconformances and/or equipment out of tolerance investigations. Provides overall support to maintaining the quality management system, including performing/assisting with audits. Leads formal problem resolution teams.

What you'll do:

• Evaluates complaints, nonconformances, and/or equipment out of tolerance investigations to determine appropriate level and type of response actions, as well as ensure thorough root cause analysis and effective corrective actions.
• Manages and evaluates CAPA trending data effectively.
• Tracks and trends final inspection results and returned graft dispositions.
• Creates and revises Standard Operating Procedures consistent with GMP/GTP, AATB, and ISO requirements.
• Leads teams to resolve problems using formal methods, such as 8D.
• Develops, enhances, and monitors systems for final inspections and returned product inspections for all products.
• Evaluates/audits QMS processes as assigned to ensure procedural compliance and effectiveness.
• Reviews reports and assists with follow up of findings from ISO, FDA, AATB, and state audits.

What you'll bring (Minimum Requirements):

• Bachelor's Degree; Bachelor's degree from four year accredited college; BS in Engineering, Biological Sciences, Allied Health field or Policy Administration, preferred
• Three (3) years' professional work experience in quality or operations related activities in tissue banking, pharmaceutical, medical device, or clinical trial; Allied health experience as health professional or support services, critical to other health professionals, preferred
• Valid Driver's License
• AATB Certified Tissue Banking Specialist (CTBS) preferred

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

• Industry regulations standards, and guidelines: Able to review requirements, determine relevance to processes within the organization, and ensure compliance as applicable; Familiarity with applicable tissue banking/medical device related regulations, standards and guidelines: 21 CFR 1271, 21 CFR 820, ISO 13485, AATB Standards
• 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
• 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: Experience to anticipate and critically think through problems. Advanced knowledge problem resolution tools
• Microsoft Office: Proficient in Microsoft Office and Adobe Pro

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 Plan
• Affordable medical, dental, and vision coverage
• Corporate sponsored events for employees
• Work-life balance with generous paid time off to include vacation time, sick time, and paid holidays
• Tuition reimbursement
• Personal career, skill, and leadership development opportunities
• Wellness Program (gym reimbursement, monthly wellness webinars, mental health toolkit, financial resources, and much more)
• Employee Assistance Program (EAP) for employees and members of their household
• 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.