Staff Quality Engineer (Medical Device/Combination Product) bei BlueRock Therapeutics
BlueRock Therapeutics · Toronto, Kanada · On-site
- Optionales Büro in Toronto
BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.
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.
This position provides hands-on Quality Assurance support to cross-functional product development teams. This role is responsible for applying medical device and combination product quality principles in a phase-appropriate, risk-based manner, ensuring compliance with applicable regulations while enabling efficient development progress.
The ideal candidate is a self-directed quality professional with strong experience in medical device design controls, risk management, and combination product requirements. You will act as a trusted quality partner to R&D, Manufacturing, Regulatory, and external partners, helping teams navigate complex technical and regulatory challenges.
Responsibilities
- Design Controls & Product Development
- Serve as the Quality representative on medical device and combination product development teams from proof-of-concept through clinical readiness and launch.
- Provide proactive guidance on medical device design controls in accordance with 21 CFR 820, ISO 13485, and applicable internal procedures.
- Review and approve design control deliverables including Design Inputs, Design Outputs, Design Reviews, Design Verification and Validation, and Design History File (DHF) documentation.
- Support integration of device constituent quality requirements within combination product development programs (21 CFR Part 4).
- Risk Management & Human Factors
- Lead and facilitate risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, system risk assessments, and risk-benefit evaluations.
- Review and approve Risk Management Files and ensure appropriate linkage to design controls and verification/validation activities.
- Support human factors and usability engineering activities, including formative and summative usability studies, as applicable.
- Manufacturing & External Partners
- Partner with Device Development and Contract Manufacturing Organizations (CMOs) to support manufacturing process development, characterization, and validation.
- Review and approve manufacturing-related documentation such as manufacturing plans, manufacturing instructions, process FMEAs, process validation protocols and reports.
- Support supplier qualification activities, including supplier audits, quality agreements, and ongoing supplier performance oversight.
- Quality Events & Continuous Improvement
- Review, approve, and as needed lead investigations related to deviations, nonconformances, and complaints with impact to medical devices or combination products.
- Lead or support root cause investigations and development of effective CAPAs.
- Contribute to continuous improvement initiatives related to design control processes, risk management practices, and quality system effectiveness.
- Quality System & Compliance
- Author, review, and revise Quality System procedures related to medical device and combination product development.
- Maintain current knowledge of applicable global regulations and standards, including FDA, ISO, MDR, and MDSAP requirements.
- Support internal audits, supplier audits, and inspection readiness activities as required.
Minimum Requirements
- Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or a related scientific discipline AND 8+ years of experience in Quality Assurance supporting medical devices and/or combination products, or equivalent education and years of experience.
- Demonstrated hands-on experience with medical device design controls and Design History File management.
- Strong working knowledge of applicable regulations and standards, including 21 CFR 820, ISO 13485, ISO 14971, and combination product requirements (21 CFR Part 4).
- Experience with quality event management, root cause analysis, and CAPA within a regulated environment.
- Ability to work independently, exercise sound judgment, and communicate effectively with cross-functional stakeholders.
- Preferred Requirements:
- Combined experience in pharmaceutical and medical device development environments.
- Master’s degree in Engineering, Life Sciences, or a related field.
- Experience supporting clinical trial readiness and clinical supply release for device or combination products.
- Strong background in risk management across the full product lifecycle, from early development through launch.
- Experience working with CMOs and contract testing laboratories, including audits and quality agreement management.
- Knowledge of statistical methods applied to quality and validation activities.
- Salary Range: $125,000-$150,000/yr + Bonus
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