Quality Engineer

POSITION SUMMARY:

Quality Engineer is supporting early to late stage Laboratory development and In Vitro Diagnostic (IVD) Test. This is an exciting opportunity for an ambitious and dynamic individual to join a fast paced rapidly growing company. 

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

Preferred skills:

• 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