Sherlock Biosciences is an exciting new diagnostic company, based on next-generation CRISPR and Synthetic Biology technology platforms. We are seeking a Quality Engineer will help implement Sherlock Biosciences’ quality strategy for the full product life cycle of Sherlock Biosciences’ products, from concept to development to product release.
The successful candidate will join an exciting and fast-paced team focused on improving human health worldwide through highly innovative CRISPR and Synthetic Biology-based platforms for molecular diagnostics. We recently received FDA Emergency Use Authorization for our CRISPR SARS-CoV-2 kits to detect the virus that causes COVID-19. This is the first FDA-authorized use of CRISPR technology.
- Develop quality plans for various Sherlock Biosciences’ test kits to assure that associated supplier quality, manufacturing processes, product test activities, and post-market product performance support ISO, EN, and IVDDR certification and compliance with FDA regulations.
- Support R&D on new product development programs by ensuring QA manufacturing controls are in place.
- Review and approve device master record and device history record documentation for Sherlock Biosciences’ products.
- Support Operations and R&D in troubleshooting process/product problems, defining root causes, implementing corrective actions and verifying corrective action effectiveness.
- Collaborate with Operations and R&D to improve efficiency, reliability and effectiveness of manufacturing and product testing processes.
- Develop verification and validation protocols for Sherlock Biosciences quality system and manufacturing processes; execute protocols and generate reports as necessary.
- Manage Document Control Process.
- Develop IQ, OQ and PQ protocols for measurement, test, quality system, R&D and manufacturing equipment/software; execute protocols and generate reports as necessary.
- Manage Complaint Process including complaint investigation, record keeping and trend reporting.
- Develop and manage Corrective and Preventative Actions (CAPA).
- Perform Internal/External Quality Audits (including audits of CMOs and key suppliers).
- Manage non-conformance activities; serve as Material Review Board QA representative.
- Generate quality reports that track trends in: supplier quality, in-process test results, finished product yield, complaint trends, CAPA status and audit status.
- Travel to vendors as needed for audits, ~10% travel
Skills, Qualifications and Experience:
- BS or MS in related Life Science field with 3-5 years industry Quality Management experience, ideally within an In Vitro Diagnostic manufacturing/production environment,
- Experience at a small company/start-up setting preferred.
- ASQ or six Sigma certification or equivalent is desired.
- Proven experience in Quality Systems with an emphasis on ISO 13485, IVDDR and 21CFR Part 820.
- Experience with full product life cycle, from concept to development to product release.
Word processing, spreadsheet, Internet, e-mail, manufacturing, and database software
Knowledge of Inspection techniques and equipment.
Ability to define problems, collect data, establish facts, and draw valid statistical conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.
Ability to read and interpret component/material specifications and apply appropriate test methods to inspect the components/materials associated with these documents.
Excellent organizational, record keeping and communication skills (oral and written),
A strong work ethic to generate high quality work under tight deadlines,
A commitment to collaborating with diverse organizational elements,
A proactive attitude
The ideal candidate will be prepared to BE GREAT!
Boldness - We will push boundaries and confidently confront any challenge.
Excellence - We will be our best and help our team members be their best.
Growth - We will support each other to advance our careers and achieve our personal goals.
Respect - We care about ourselves and each other, behaving honestly and with integrity.
Equity - We will build a diverse and inclusive team which treats each other as we expect to be treated.
Accountability - We expect the team and hold each other responsible to meet our obligations.
Trust - We will be open in our communications and support anyone acting on our core values.
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