Posted by: LifeNet Health on Feb 25, 2019
Virginia Beach, VA
The LifeNet Health mission is simple: Saving Lives. Restoring Health. Giving Hope. Its mission, along with its core values of safety, quality, innovation and service continue to create an unmatched record in transplant solutions, which cannot be achieved without talented, dedicated team members who share the same values and attributes that guide the LifeNet Health team every day.
If you have a commitment to customer care, quality and innovation as well as integrity and passion, then you've come to the right place.
We are currently seeking a Quality Engineer to join the LifeNet Health team in our Virginia Beach, VA location.
The Quality Engineer role serves the purpose of an internal consultant as well as responsible for risk mitigation through various processes e.g. Employee Safety and Supplier Quality Processes. Further this role ensures that introduction of new product into production is compliant with GTP, GMP, ISO, and OSHA requirements.
You would be expected to perform all tasks assigned to you, including but not limited to:
Effectively executes the Supplier Quality program including: On-site Supplier Quality Audits, improvement action throughout supply chain and conducts effective execution of Supplier selection process.Provides Quality and Reliability Engineering Support to Value Streams including approving protocols for various process and product qualification studies e.g. IQ, OQ, PQ.Leads Corporate Employee Safety Program including leading large cross-functional teams for successful execution of Safety Program including ensuring corporate compliance with applicable OSHA regulations and company policies. Acts as the corporate safety officer.Provides Quality Engineering support to New Product Development teams in the design control process.Manages the Terminal Sterilization Process through irradiation dose audits and tracks and trends the results. Evaluates the requirement to escalate the need for execution of the reaction plan.Executes Quality Engineering aspects of Incoming Receiving Inspection Process including non-conforming review board process (NCRB) and subsequent follow up with supplier to prevent recurrence.Leads teams to resolve problems using formal methods, such as 8D, 5-why, Ishikawa diagrams, etc.Qualifications:
Bachelor's Degree in EngineeringAuditor training by a reputed organization (such as BSI, AIAG, etc.) - Current or obtain within six months of employment3 years' Experience and involvement in team projects. Knowledge of CAPA process - Root cause investigation and determination and corrective and preventive actionsLEAN/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 areasCommunication skills Ability to communicate effectively with a variety of suppliers and internal customersPreferred:
Master's Degree in Engineering or any field if have BA/BS in Engineering Auditor training by (ASQ) American Society for QualityCertified Quality Engineer2 years Project Management experience2 years' experience working with Suppliers - Supplier Management Experience2 years' experience in the medical device and/or pharmaceutical industry is preferred.1 years Employee Health & Safety ExperienceOSHA Regulations - State and federal regulationsGet to Know LifeNet Health:
LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization ("OPO") and tissue bank in the United States, as well as a leading innovator in transplantation research and regenerative medicine. LifeNet holds the longest running current accreditation by the American Association of Tissue Banks (AATB). Its goal is to improve the quality of human life through the provision of organs and tissues for transplantation, as well as innovation in the fields of bio-implants and regenerative medicine, and to serve the community with educational and support services that enhance the donation process.
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. #LI-AF1
HR. Website URL: