Microbiology Quality & Sterility Assurance (MQSA), Scientist
About The Position
The MQSA Scientist will serve as a technical leader in microbiological quality, sterilization, and reprocessing, partnering across product development and manufacturing teams to support safe, effective, and compliant medical devices. As a site subject matter expert, this individual will apply technical knowledge and scientific expertise to strengthen microbiological controls, advance sterilization strategies, and help ensure the highest standards of product quality. This role offers the opportunity to contribute directly to patient safety while collaborating with a talented team of scientists and engineers.
Requirements
- Bachelors or equivalent university degree in Microbiology, Biomedical Science, Engineering, Sterility Assurance, Food Science or related field.
- Minimum of 2 years of sterilization/microbiological experience in the medical device, pharmaceutical and/or food science industries.
- Solid understanding of applicable FDA (QMSR) regulations.
- Experience in the field of microbiology or quality assurance, in the production of sterile products.
- MS Office skills.
- Strong teamwork and interpersonal skills.
- Analytical and critical thinking skills are essential with strict attention to detail.
- Must be fluent in spoken and written English.
Nice To Haves
- Experience writing standard operating procedures, validation protocols, and validation reports.
- Knowledge of EU, cGMP and cGLP regulations is strongly preferred.
Responsibilities
- Works with Product Development Teams to ensure the microbiological quality requirements are established and met based upon the customer and regulatory needs.
- Develops radiation sterilization validations or product adoptions of new products.
- Develops/validates reusable medical device reprocessing instructions (i.e., cleaning, disinfection and/or sterilization) or adopts products into existing health care facility clinical processing instructions.
- Coordinates the requalification activities needed to ensure a compliant Ethylene Oxide (EO) sterilization program.
- Investigation of non-conformances, and implementation of corrective actions, and recommend disposition of product.
- Preparation and evaluation of trending data. Increases awareness of out of specification (OOS) results.
- Preparation and routing of documents for the change request/change order processes.
- Experience writing standard operating procedures, validation protocols, and validation reports.
- Compliance with GMP/GDP requirements and guidelines.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
