Quality Engineer 1

POSITION SUMMARY:

PRIMARY RESPONSIBILITIES:

• Create, revise and update laboratory, equipment, facility, HIPAA Privacy & Security and quality processes compliance
• Develop and implement quality system documentation (operating procedures, work instructions, specifications etc.)
• Primary support for compliance activities (management of non-conformances, CAPA, environmental monitoring, process monitoring, audits, complaints investigations)
• Conduct or facilitate internal and external audit of product processes and recommend improvements (eg. Notified Body, FDA, HIPAA)
• Participate in CAPA, Deviation, and Non Conformance investigation and reporting
• Perform Risk Assessments (e.g. FMEA, FTA, Risk Analysis) with cross-functional team
• Monitor and audit laboratory scientist’s process workflow for compliance to HIPAA/ CLIA/ GMP/GLP/GCP and recommend updates
• Participate in test method optimization, qualification, and validation as required
• Perform quality assurance for sample testing in support of new products
• Perform statistical analysis/hypotheses testing (AQL’s etc)
• Implement and monitor Statistical Process Control (SPC)
• Maintain Quality systems compliance to CLIA, FDA QSR, ISO 13485, GMP, GCP, GLP and HIPAA
• Participate in the management of Approved Suppliers
• Record and review original test data and follow established company standard operating procedures and good documentation practices
• Perform raw data and analytical testing review of in house and contract testing labs
• Participate in laboratory maintenance activities, including coordinating and monitoring supply inventories and equipment maintenance and calibration status
• Provide data policy and security industry expertise and advisory services to projects that involve healthcare data privacy regulations
• Establish recommended HIPAA privacy and security practices
• Interact with client data privacy and security resources to define the necessary policies and procedures to comply to the relevant regulations
• Stay current on applicable regulations and guidance from FDA, ISO13485, CLIA, aaBB, OSHA, EH&S, HIPAA, etc
• Work as a member of a fully integrated team
• This role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) in order to perform the job.
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on Natera training requirements.
• Other duties as assigned

QUALIFICATIONS:

• Position requirements are a B.S. or equivalent in science, engineering or related field
• At least 2 to 5 years experience or equivalent in Quality process improvement in 21 CFR 820 QSR, SOR 98/282, IVDD, ISO13485, GMP/GLP/GCP/HIPAA environment with medical devices, CLIA laboratory, or Life Sciences industry
• American Society of Quality certifications (CQE, CMQ/OE) preferred
• Extensive experience with ISO 14971

KNOWLEDGE, SKILLS, AND ABILITIES:

• Computer skills (MS Word, Excel, PowerPoint, etc.)
• Good technical writing and communication skills
• Independent worker, a self-starter with strong organizational and planning skills 
• Has an ability to be productive and successful in an intense work environment

• Hands on experience with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, Bioinformatics etc.
• Demonstrated good judgment, excellent attention to detail, excellent written, verbal communication and interpersonal skills are desired with the ability to be flexible and collaborate on multiple projects

OUR OPPORTUNITY

WHAT WE OFFER