BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation of cellular medicines. Utilizing our proprietary CELL+GENE™ platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases.
Founded in 2016, BlueRock is at the forefront of the convergence of cell biology and genetic engineering. Our mission is to harness pluripotent stem cell technology and gene editing to deliver authentic, functional cell therapies that address the root causes of disease and offer hope to millions of patients worldwide.
What Are We Doing?
Our foundational science enables the generation and directed differentiation of universal pluripotent stem cells into authentic, functional cells for allogeneic cellular therapies.
We are passionate about realizing the promise of cell and gene therapy, shaping the future of regenerative medicine, and delivering new therapies to patients with limited or no treatment options.
Who is BlueRock?
BlueRock Therapeutics LP is a clinical stage cell therapy company 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.
Description Of Position
Quality Engineer III provides end-to-end device quality support for drug-delivery and cell-delivery devices used in BlueRock Therapeutics' clinical programs. The primary focus is downstream sustaining quality for devices after design transfer. You will utilize knowledge and skills to provide support for trial readiness, lot disposition, complaint management and investigation, and quality oversight of contract manufacturers (CMOs) and off-the-shelf (OTS) device vendors. The role also supports device development activities under design controls (ISO 13485 and 21 CFR Part 820) as assigned. It works closely with Device Engineering, Supply Chain, Clinical Operations, CMC, and external manufacturing partners to make sure devices are safe, compliant, and available for every scheduled surgery.
Responsibilities
As a Quality Engineer III, you will be responsible for providing quality support for clinical readiness and sustaining of Medical Devices and Combination Products. You are expected to be a self-directed professional who can identify issues, communicate effectively to cross functional team members, have a focus on quality, and help in completing critical deliverables.
Clinical Trial Device Quality & Sustaining
- Perform quality review and disposition of device batches and lots for clinical use, including review of device history records, certificates of conformance, and supporting documentation.
- Own device complaint handling for clinical programs: intake, evaluation, investigation, root cause analysis, trending, and closure. This includes combination-product device constituent and OTS device complaint obligations.
- Manage device-related quality issues at clinical hubs and sites, and coordinate containment, investigation, and communication with internal and external stakeholders.
- Provide device quality support for trial readiness activities, including mock runs, site/hub readiness, and on-call support on the day of surgery.
- Support deviations, nonconformances, and CAPAs related to clinical devices, including impact assessments and effectiveness checks.
- Evaluate and approve process changes at CMOs and vendors for impact on device quality, validated state, and clinical supply.
- Lead or support operational improvement projects that affect device handling and use in the clinical workflow (e.g., environmental/air qualification, packaging and tote improvements).
Supplier & CMO Quality Oversight
- Serve as the device quality point of contact for assigned CMOs and OTS vendors. Drive corrective action implementation, change control, and issue resolution for devices used in BlueRock programs.
- Monitor supplier performance and escalate quality risks affecting clinical supply.
Device Development Quality (as assigned)
- Support design control activities for devices in development, including risk management deliverables per ISO 14971.
- May provide quality oversight of engineering confidence testing and V&V activities.
- Support manufacturing process development and readiness at CMOs ahead of design transfer (e.g., process FMEA, process validation planning, inspection strategy).
- Contribute to design history file (DHF) and device master record (DMR) documentation.
Minimum Requirements
- Bachelor’s Degree or equivalent in a scientific/engineering discipline (chemical, mechanical or biomedical engineering)
- 4+ years experience working in a Quality Assurance role for medical device/combination product
- Working knowledge of design/operation of medical device or drug combination product platforms, design controls, risk management, 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
- Hands-on experience with CAPA, deviations, change control, and root cause analysis tools (e.g., 5 Whys, fishbone, fault tree).
- Experience working with CMOs and external suppliers on issue resolution and corrective actions.
- Exposure to design controls and risk management (DFMEA/PFMEA) in a development setting.
- ASQ certification (CQE, CQA) or equivalent is an asset.
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.
The estimated compensation range for this position is $ 92,000.00 - $ 97,200.00 per year.
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
