The Senior Quality Engineer is an enthusiastic, self-motivated person with great communication skills who can work under limited supervision to support our quality management and regulatory systems development and management. The Sr. Quality Engineer will demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below.
The candidate will be comfortable in a rapidly evolving Biotech environment designing, implementing and evolving a value added QMS based on CLIA, CAP, CLEP, ISO 13485:2016 and FDA QSR regulations.
- Provide quality guidance, support, and leadership in the design and development of technology transfer processes for new clinical laboratory equipment, instruments, and systems.
- Collaborate with project team members and other stakeholders to determine quality system requirements for implementation of new laboratory testing systems.
- Lead/participate on cross functional teams responsible for implementing new programs, tests, methods, instrumentation, and procedures and ensure compliance to company policy and regulatory requirements.
- Provide quality engineering support to Laboratory and Procurement departments in the evaluation and management of Supplier Quality program, including conducting supplier audits and assisting Procurement personnel in resolution of Supplier Quality issues.
- Creating, updating, reviewing and developing Quality Management System standard operating procedures and supporting work instructions based in CLIA, CAP, CLEP, ISO 13485:2016 and FDA Quality System Regulations.
- Mentor quality and laboratory personnel in requirements of quality tools and techniques, QMS based on CLIA, CAP, CLEP, ISO 13485:2016/FDA 21 CFR 820 requirements and industry best practices.
- Support internal and regulatory audits of quality management functions, processes, and procedures.
- Perform any and all additional tasks or responsibilities as directed by your manager.
- B.S./B.A. in Engineering, Chemistry or Life Science. Advanced education a plus.
- 5+ years as a Quality Engineer or equivalent.
- Experience in high complexity CLIA clinical laboratory or medical device environment with knowledge of design controls, CLIA, CAP, CLEP, ISO 13485:2016/FDA QSR quality systems, lead auditor training, and process development, qualification, and validation.
- Ability to apply quality tools to develop new quality processes focused on process rigor and reduction in variation throughout operations.
- Critical to have a working knowledge of quality engineering techniques and methodologies and ability to apply across a variety of situations and/or processes.
- Experience in medical device / Biotech start-up / fast growth company, or similar working environment.
- Basic understanding of Chemistry and Molecular Biology, as it pertains to DNA sequencing preferred.
- Working knowledge of cGxP's.
- ISO 14971 and ISO 15189 experience a plus.
- ASQ CQE and other ASQ certifications highly preferred.