Job Description

Since 2007, Genalyte has been guided by the vision of performing panels of blood tests and receiving results within a few minutes. As we look to the future, Genalyte’s technology will transform health care- moving lab testing from the lab into the physician’s office.  

We are well funded with outstanding growth potential. We are looking for individuals inspired by our technology and vision, who are eager to be at the ground level of this collaborative and entrepreneurial company. 

We want to hire individuals who are interested in creating an innovative, fast-paced and dynamic work setting. We offer a competitive salary and benefits package to attract, motivate, and retain the highest caliber of employee.

About the role: 

We are seeking a Senior Quality Engineer to own all QA activities in support of our Maverick instrument. The ideal candidate has a wide breadth of med device quality engineering experience with ISO 13485. Your quality engineering experience should also include: Design Controls, Validation and Risk Management

Additional duties:

• Partner with subject matter experts to identify, define and document product specifications, sampling and testing requirements, stability processes, validation requirements (plans, protocols and reports), assisting with investigations of clinical and commercial diagnostics and consumables manufactured by the company. 
• Provide expert guidance and oversight to the development of equipment and process validation activities and partner with team members during the implementation and execution of validation and qualification plans, protocols, and reports. 
• Lead and facilitate product and process risk management activities including facilitating risk assessments and FMEA, DFMEA, PFMEA with cross functional teams, maintaining risk management files, and participating in risk analyses associated with design changes, complaint handling, and failure analyses.
• Provide guidance and support to investigations and corrective/preventive actions related to non-conformances identified through CAPA, post market surveillance plan development, customer feedback analyses, and provide product support as required to determine deficiencies in the quality system, product and manufacturing processes.
• Provide quality oversight and guidance to medical device software, SDLC process, diagnostic instrument, and consumable product realization processes, ensuring adherence to company procedures and applicable ISO 13485:2016 and FDA design control (820.30) requirements.
• Assists with supplier, certification body, and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good Manufacturing Practices implemented by the company.
• Works independently or with cross-functional teams to lead and support multiple projects, balancing priorities, and resources to meet project and management expectations.

About You 

• Bachelor's degree or higher in a scientific field, 10+ years hands on experience as a senior level quality engineer in the medical devices, pharmaceutical, or In Vitro fields.
• Minimum of 5 years of hands-on experience developing and executing equipment qualifications and validations, software tool validation, and writing design validation plans, protocols, and reports for IVD instruments.
• Extensive experience developing and implementing Corrective and Preventive Actions (CAPA) plans, leading Failure Mode Effects Analysis (FMEA), leading root cause analysis (RCA), implementing continual Improvement initiatives and well-versed in problem-solving methodologies (Kaizen, Lean, Six Sigma, etc.).
• Advanced knowledge and experience with statistical tools and methodologies used in data analysis activities.
• Minimum of 5 years of experience leading internal audits and representing organizations as the point person for certification and regulatory body and supplier audits. FDA inspection experience is a must have. ASQ Certified Quality Auditor certification is desired. 
• Substantial working knowledge and experience with implementing and maintaining Quality Management Systems that adhere to Quality System Regulations and International Standards including: 21 CFR 11, 21 CFR 820, ISO 13485, ISO 14971, EN 62366, EN62304 and In Vitro diagnostics regulations.
• Expert knowledge and experience with ISO 13485:2016 and 21 CFR 820 are required.
• Experience leading cross-functional teams including, but not limited to Complaint Handling Units, CAPA Review Boards, Risk Analyses and Assessments, Root Cause and Failure Analyses, and Material Review Boards. 
• Strong presentation skills and excellent verbal and written communication skills are a must. Candidate must be comfortable presenting quality concepts and ideas to individuals at all levels.

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