Lead Quality Engineer, Microbiology and Sterilization

Role Summary:

The Lead Quality Engineer, Microbiology and Sterilization, serves as Capstan Medical's quality subject matter expert for sterility assurance and microbiological control. This role leads quality engineering oversight of the ethylene oxide (EtO), moist heat (autoclave), and liquid chemical sterilization processes that support Capstan's sterile products, along with the supporting microbiology and contamination control programs. The role partners closely with R&D, Operations/Manufacturing, Regulatory Affairs, Supplier Quality, and third-party sterilization and laboratory partners to ensure these activities meet Capstan Quality System requirements and applicable regulatory and standards expectations.

Core Responsibilities

Sterility Assurance Leadership

•Serve as Capstan's quality subject matter expert for sterility assurance and microbiology, setting sterilization and microbiological control strategy with R&D, Operations, and Regulatory Affairs.

•Provide technical guidance, training, and mentoring to quality engineers, technicians, and cross-functional partners on sterilization and microbiology topics.

•Author or review sterilization and microbiology content for regulatory submissions and support responses to agency questions.

Sterilization Validation and Routine Control

•Lead quality engineering oversight of EtO (ISO 11135), moist heat/autoclave (ISO 17665), and liquid chemical (ISO 14160) sterilization processes, including development, validation, routine control, monitoring, requalification, and change assessment.

•Review and approve sterilization validation protocols and reports, including half-cycle/overkill approaches, product family and process challenge device (PCD) rationale, biological indicator (BI) placement, and load configurations.

•Define and maintain sterilization lot release requirements, including review of cycle parameters, BI and PCD results, and sterilization records prior to product disposition.

•Ensure sterilant residual requirements, including EtO residuals per ISO 10993-7, are defined, tested, and met.

•Partner with Packaging Engineering to ensure sterile barrier systems and shelf-life studies support sterility maintenance (ISO 11607).

Microbiology and Contamination Control

•Lead the bioburden program, including method validation and recovery efficiency, routine monitoring, alert/action levels, and trending (ISO 11737-1).

•Develop and oversee tests of sterility performed in support of sterilization validation and requalification (ISO 11737-2), as well as biological indicator qualification and use (ISO 11138).

•Define bacterial endotoxin testing requirements and limits (ANSI/AAMI ST72), develop in-house test methods and oversee routine testing.

•Develop and maintain cleanroom environmental monitoring and contamination control, including viable and non-viable monitoring, alert/action limits, excursion response, and trend review (ISO 14644).

•Serve as the quality point of contact for contract sterilizers and contract microbiology laboratories, including audits, technical agreements, method transfers, and data review.

Investigations, CAPA, and Audits

•Lead investigations into sterilization deviations, BI and sterility test positives, bioburden and endotoxin excursions, and environmental monitoring excursions, including root cause analysis, product impact assessment, and CAPA.

•Participate in Material Review Board as the sterilization and microbiology subject matter expert.

•Trend and analyze sterilization and microbiology data to identify adverse trends and drive continuous improvement.

•Represent sterilization and microbiology during internal audits, supplier audits, certification body audits, and regulatory inspections, including evidence preparation and responses.

Documentation and Compliance

•Create, review, and approve SOPs, work instructions, protocols, reports, and quality records related to sterilization, microbiology, and contamination control.

•Ensure activities comply with Capstan Quality System requirements and applicable regulations and standards, including FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and the sterilization and microbiology standards above.

Skills

•Expert knowledge of sterilization science and sterility assurance, including sterility assurance level (SAL), overkill and bioburden-based approaches, D-values, and microbial resistance.

•Working knowledge of EtO (ISO 11135), moist heat (ISO 17665), and liquid chemical (ISO 14160) sterilization standards; familiarity with radiation sterilization (ISO 11137) is a plus.

•Strong knowledge of microbiological test methods and standards, including bioburden and sterility testing (ISO 11737-1/-2), biological indicators (ISO 11138), endotoxin testing (USP <85>/<161>, ANSI/AAMI ST72), and cleanroom environmental monitoring (ISO 14644).

•Strong knowledge of medical device quality systems, including risk management, process validation, nonconformance/CAPA, change control, and supplier controls.

•Excellent investigation, root cause analysis, and data analysis skills, with ability to make sound, risk-based product impact recommendations.

•Strong written and verbal communication skills; able to explain microbiological risk clearly to R&D, Operations, auditors, regulators, suppliers, and contract laboratories.

Requirements

•Bachelor's degree in Microbiology, Biology, or a related life sciences or engineering field; Master's degree or certifications such as AAMI Certified Industrial Sterilization Specialist (CISS), RM/SM (NRCM), CQE, or CQA are a plus.

•7+ years of experience in medical device sterilization, microbiology, or quality engineering, including leading sterilization validation and microbiology programs for sterile devices; Class III or implantable device experience is a plus.

•Hands-on experience with validation and routine control of EtO, moist heat, and liquid chemical sterilization processes.

•Experience managing contract sterilizers and contract microbiology laboratories.

•Experience leading microbiological investigations, NCRs, and CAPAs, including effectiveness verification.

•Experience supporting cleanroom manufacturing environments and external audits or inspections.

•Ability to work onsite and cross-functionally with R&D and Operations teams as needed.

Why join us:

We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients

We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off

We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!

 We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.