Quality Engineering Specialist II (Medical Device)

BlueRock Therapeutics is a next-generation regenerative medicine company focused on breakthrough treatments and new horizons in medicine. BlueRock Therapeutics’ platform is based on state-of-the-art pluripotent stem cell engineering tools and PSC expansion and differentiation technologies. Our vision at BlueRock is to cure cardiovascular, neurologic and immunological diseases with significant unmet need and diminished self-repair potential. Our platform is enabled by strategic partnerships with leading academic and industry collaborators in the U.S., Canada and Japan.

BlueRock`s ambition is to have a team of dynamic and highly engaged top scientists who are inspired to take project ownership and further develop themselves in one of the most rapidly growing scientific fields. At BlueRock we value open communication, collaboration and a positive and fun working environment in which both individual and team contributions are recognized. Our world-class management team is committed to fostering the growth and career development of employees.

BlueRock is seeking a Quality Engineering Specialist, reporting to the Senior Director of Quality.

This is an outstanding opportunity for a talented individual to contribute to bringing a new class of medicines to patients and gain valuable career experience in translational medicine. Collaboration with a highly-motivated, world-class team of scientists and engineers promises an exciting and engaging work environment for motivated, self-starting candidates.

Position Description:

The Quality Engineering Specialist (Medical Device) will be responsible for approving design control deliverables, assisting investigation and design change closure in a timely manner, supporting review of regulatory product submission filings and supporting continuous improvement efforts for medical device development related processes.

Responsibilities:

• Subject matter expert in the statistics of quality including sample size analysis, power calculations, confidence and reliability, capability analysis, etc.
• Work closely with cross-functional device development teams as a quality assurance specialist ensuring compliance with company QMS requirements, device Design Control procedures and relevant regulations.
• Work with R&D, Product Engineering and Quality Control to establish acceptance criteria, test methods and related validations to assure product quality.
• Author R&D/Quality procedures for maintenance/creation of design history files and other supporting documentation.
• Review and approve R&D/Quality documentation (e.g. Design History Files, Design Control documents, FMEA, Risk Management files, Verification/Validation documentation)
• Lead and facilitate Risk Assessment and Mitigation. Review and approve risk management documents
• Provide guidance and support to device development team in their verification and validation efforts to ensure compliance.
• Review and approval of quality issues (e.g. deviation, investigations) and technical matters (e.g. design changes, verification and validation protocols and reports) with impact to design control and risk management. As required, lead investigations, root cause analyses and CAPAs.
• Perform supplier audits
• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercise judgment within generally industry defined practices and policies in selecting method and techniques for obtaining solutions. Requires thorough knowledge of FDA, ISO, and other regulatory guidelines related to the manufacturing of medical devices.
• Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed
• Assist with implementation of Quality Systems to cover all aspects of compliance with medical device and cGMP regulations (21CFR820, EU MDR, ISO 13485, 14971, 10993). Maintain knowledge of current industry standards and trends in best practices.
• Other quality duties as assigned (e.g., document control, quality event review, training, batch record review and disposition, etc.)
• Bachelors Degree in scientific or engineering discipline (chemical, mechanical or biomedical engineering) and 8+ year’s work experience or Master’s Degree in scientific or engineering discipline (chemical, mechanical or biomedical engineering) and 6+ year’s work experience, CQE credential desired
• Strong knowledge of medical device QMS requirements (21CFR820, MDR), ISO requirements for medical device production (ISO 13485) and medical device testing (ISO 10993)
• Deep experience in statistical analysis including strong knowledge of statistics of quality and experience with least one statistical analysis software system.
• Possess a working knowledge of drug regulations and industry standards including GMP and applicable guidance documents, ICH guidance documents, USP, ISO and associated global regulations (EU, Japan)
• Experience in QMS development and QA operations in a GMP-regulated environment with experience in cell and gene therapy highly desired
• Proven ability to identify quality issues and effectively and proactively investigate and efficiently resolve issues in a team setting
• Experience working with contract manufacturing organizations (CMOs) and contract testing labs including auditing, negotiation of Quality Agreements, and resolving quality issues
• Strong technical writing skills with working knowledge of MS office programs, such as Word, Excel, SharePoint, Access and Adobe Acrobat professional

Minimum Requirements:

BlueRock Therapeutics is an equal opportunity employer and supports workforce diversity. BlueRock welcomes and encourages applications from people with disabilities. Accommodations are available by request for candidates taking part in all aspects of the selection process.