We are seeking a highly motivated and experienced Director, Quality Engineering to join the exciting area of molecular diagnostic products. The primary focus is to use our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19, infectious disease, oncology, and other potential molecular diagnostic innovations. This qualified candidate will build and oversee the product development quality team to ensure programs are resourced and supported appropriately. This role is responsible for setting the quality expectations across products to build a high level of consistency and efficiency, applying quality engineering, design control and risk management principles to achieve the development of high quality diagnostic products, including software, and customer satisfaction that will improve patient outcomes. This individual will have overall responsibility for leading the improvements and management of the design control quality processes, including setting related quality goals and metrics to ensure compliance. In this hands-on role, the individual will work closely with the regulatory, engineering, marketing, project management, operations, and commercial teams to maintain compliance to 21 CFR 820 and ISO 13485 and to also support development of research use products. The ideal candidate should be strategic, able to work in a fast-paced work environment, flexible, analytical, able to lead and motivate teams, as well as run independently. This is an exciting opportunity for a passionate, hands-on, data-driven, ambitious individual who thrives in a dynamic environment.
Who we are:
We are a fast-growing life sciences reagents and software company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19. You will join a team of highly talented people in a well-funded, exciting environment.
What you will be responsible for:
- Provide quality engineering support for new product development from feasibility through clinical and into commercialization, including lifecycle management, to ensure design control requirements are met.
- Work effectively and guide multiple functions (R&D, Operations, Commercial, Regulatory, Supply Chain, Clinical, etc.) to ensure design control expectations are met and understood at the team and management levels.
- Lead initiative to refine design control and risk management activities according to 21 CFR 820, ISO 13485, and ISO 14971, and further develop processes that ensure compliance, agility, and consistency across products. Drive continuous improvements in this area.
- Support medical device software product development and align design controls with overall product development.
- Lead initiative to refine software design controls, specifically for verification/validation, risk management, and lifecycle management.
- Provide quality oversite and collaboration regarding risk management activities, including hazards identification, risk assessment (FMEA), and mitigation under normal and challenging conditions.
- Review/approve design control and risk management activities. Work closely with research and development, as well as operations to ensure potential product issues are identified and addressed during device design.
- Review/approve quality issues (e.g. deviation, investigations), technical matters (e.g. design changes, verification and validation), and their resolution, considering impact to design controls and risk management.
- Advise and educate technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.
- Partner/collaborate with potential 3rd parties who impact product development activities, such as review of 3rd party’s quality system and their design control deliverables, assessment of supplier changes, supplier controls (corrective actions), quality agreements, relationship development, etc., as related to product development.
- Work on complex technical problems, utilize quality engineering methods and provide innovative solutions. Support resolution of project team issues with minimal oversight.
- Provide consultation and training on design controls to internal and cross-functional groups.
- Represent the company as the quality engineering product development subject matter expert during internal and external regulatory inspections.
- Review/approve design verification plans, validation protocols, reports, and trace matrices as part of design controls to ensure robust product development deliverables that support quality, approvable products.
- Review and approve product specifications
- Key performance indicators: On-time delivery of owned QE activities (i.e., product development quality deliverables, supplier collaboration/relationship management, design control SOP improvements, etc.) and implementation of quality key performance indicator (KPI) improvements as determined through Quality Planning.
Your ideal qualifications:
- Bachelor’s Degree in sciences, engineering or other technical/scientific area
- 10+ years in medical device and/or pharma quality product development
- 2+ years of people management experience
- Understanding of software medical device regulations and guidance
- Experience with 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, Human factors Engineering and other standards and FDA guidance as related to medical device product development
- Hands on experience with design controls, including verification and validation, software, and risk management
- Experience with contract manufacturers, supplier management/relationships as related to product development
- Experience with 2nd and 3rd party quality audits
- Ability to resolve unusually complex technical problems by providing risk-based solutions that are highly innovative and strategic
- Conflict resolution skills and ability to negotiate positions based on clear technical justifications
- Ability to respond quickly to unplanned events, technical issues and changing needs from development programs by making sound quality judgment from complied factual data provided by the various functional areas, each presenting varied viewpoint of regulatory requirements or project needs and requirements
- Strong oral and written communication skills needed
- Excellent interpersonal skills required
If interested, please email resume and cover letter describing your qualifications to: firstname.lastname@example.org
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