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Senior Quality Engineer (Medical Device/Combination Product)

bluerocktx · 30+ days ago
Negotiable
Full-time
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Who is BlueRock?

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.
The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.
We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.
We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

As a Quality Engineer within the Medical Device Quality Assurance, you will work with product development teams focusing on medical devices and medical device combination products. You will utilize knowledge and skills to provide guidance to operational teams and project teams related to design controls (21 CFR 820), risk management (ISO 14971), risk assessments, Corrective and Preventative Action (CAPA) and other applicable regulatory requirements for the medical device or the device constituent of combination products. You will work with the development teams and other organizations to advance new concepts and methodologies. The Quality Engineer will be an advocate for quality, who collaborates with other functional teams reviewing design control deliverables to ensure the developed products are safe and effective.

Responsibilities:

  • As a Senior Quality Engineer, you will be responsible for providing quality support for clinical readiness of Medical Devices and Combination Products. You are expected to be a self-directed professional who has a strong grasp on Medical Device Design Control process, can identify issues, communicate effectively to cross functional team members, have a focus on quality, help in completing critical deliverables, and facilitate in explaining difficult issues. 
  • Act as the medical device quality engineer resource to support new product development.
  • Ensure device design/development and device/drug product development meets appropriate regulatory requirements by providing pro-active design control guidance through all stages of development in accordance with applicable medical device regulations, technical standards, and internal company QMS requirements. 
  • Participate in Medical Device/Combination Product Development projects as assigned. Review and approve R&D/Quality documentation (e.g. Design Inputs, Design Outputs, Design Verification/Validation, Risk Management File, Design Verification/Validation)
  • Work closely with Contract Manufacturing Organizations (CMO) to set up the manufacturing process, review and approve process design documents such as process characterization, process validation, and participate in manufacturing reviews.  
  • Work with Device Development to establish and/or review acceptance criteria, test methods, protocols, instructions and related validations to assure product quality.
  • Lead and facilitate Risk Analysis, Control and Mitigation per ISO 14971. Review and approve risk management file documents.
  • 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.
  • 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.
  • Contribute to establishing, maintaining and revising internal procedures.  Maintain knowledge of current industry standards and trends in best practices.
  • May perform supplier audits and qualify new suppliers.
  • May author R&D/Quality procedures for maintenance/creation of design history files and other supporting documentation.
  • Other quality duties as assigned (e.g., document control, quality event review, training, batch record review and disposition, etc.)

Minimum Qualifications:

  • Bachelor’s Degree or equivalent in a scientific/engineering discipline (chemical, mechanical or biomedical engineering) with a minimum of 6 years’ experience in a Quality Assurance role for medical device/combination product.
  • Technical knowledge related to the design/operation of medical device or drug combination product platforms, design controls, risk management, 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
  • At least 5 years’ experience of working in a Quality Assurance role for medical device/combination product.
  • Experience in the design and development of medical devices or combination products.
  • Knowledge and application of device root cause analysis methodology and device CAPA requirements.
  • Experience in change management of either medical devices or medical device combination products.
  • Knowledge in area of statistics of quality including sample size analysis, power calculations, confidence and reliability, capability analysis, etc.

Preferred Qualifications:

  • The combination of strong pharmaceutical and medical device development experience preferred. Master’s degree preferred.
  • Extensive experience in risk management and design control of medical devices or combination products from concept through launch.
  • Understanding and application of cGMP specifically 21 CFR 820, Rule 21 CFR “4” current good manufacturing requirements for Combination Products and the principles and concepts of relevant quality processes and systems.
  • Experience working with contract manufacturing organizations (CMOs) and contract testing labs including auditing, negotiation of Quality Agreements, and resolving quality issues.
  • Proven ability to identify quality issues and effectively and proactively investigate and efficiently resolve issues in a team setting.
  • Knowledge in statistical analysis including strong knowledge of statistics of quality and experience with least one statistical analysis software system.
  • ASQ CQE Certification.
#LI-AL1

BlueRock Therapeutics Company Culture Highlights
Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023
Winner of Comparably's Award for Best Company for Diversity 2022
Winner of Comparably's Award for Best Company for Women 2022
Winner of Comparably's Award for Best CEO 2022
BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.
Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.

Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/

Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace.  Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

Last updated on Mar 4, 2024

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