Quality Engineer II (Sterilization)

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a business unit of CooperCompanies (Nasdaq: COO), we're driven by a unified purpose of helping people experience life’s beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com

Sterility Assurance & Contamination Control

• Support and maintain Global Sterility Assurance and Contamination Control programs aligned with all applicable manufacturing sites.
• Provide quality oversight for sterilization processes including Ethylene Oxide (EO), Gamma, Electron Beam, and other applicable sterilization modalities.
• Support sterilization validation, requalification, and change assessments associated with sterilization processes.
• Review and analyze sterilization data, dose audits, cycle performance, and validation results to ensure continued state of control.
• Support contamination control strategy development and implementation across manufacturing and controlled environments including media aseptic processing.

Environmental Monitoring

• Support Environmental Monitoring (EM) programs including viable and non-viable monitoring activities.
• Review environmental monitoring trends and investigate adverse trends, excursions, and action level events.
• Partner with Microbiology and Operations teams to identify and implement corrective actions for contamination-related issues.
• Support cleanroom qualification and ongoing cleanroom performance monitoring programs.

Investigations & Continuous Improvement

• Lead and facilitate complex root cause investigations related to contamination events, EM excursions, sterilization failures, process deviations, and product quality issues.
• Utilize structured problem-solving tools such as 5-Why, Fishbone Analysis, Fault Tree Analysis, and statistical methods to identify root causes.
• Develop and implement effective CAPAs and verify effectiveness of corrective actions.

Travel:

This position may require 10-20% domestic and/or international travel.

Knowledge, Skills and Abilities:

• Working knowledge of sterilization standards including ISO 11135, ISO 11137, and applicable sterilization regulations as well as FDA 21 CFR Part 820, ISO 13485, and applicable global regulatory requirements.

• Understanding of sterility assurance principles, SAL concepts, microbiological controls, bioburden management, and contamination prevention strategies.

• Experience supporting Environmental Monitoring programs in controlled manufacturing environments including aseptic processing.

• Knowledge of cleanroom classifications, cleanroom monitoring, and contamination control practices.

• Ability to work in a matrixed organization, developing strong relationships with all levels of staff and management, partnering across multidisciplinary teams (internal/external).
• Experience supporting process validation, CAPA, nonconformance management, and change control.
• Strong time management skills to drive multiple projects to completion on time.
• Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).
• Strong data analysis, negotiation, and problem-solving skills.
• Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.
• Experience in participating in regulatory audits/inspections is preferred.
• Proficient in reading, writing, and communicating in the English language.

Work Environment:

• Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.
• Occasionally lift to 35 pounds.

Experience:

• 3+ years of experience in medical device, pharmaceutical, biologics, or healthcare industry related experience.
• Demonstrated experience supporting sterilization processes such as Ethylene Oxide (EO), Gamma Irradiation, Electron Beam, X-ray, or equivalent sterilization technologies.
• Demonstrated experience supporting sterilization validations, revalidations, and lifecycle management.
• Demonstrated experience with Environmental Monitoring, cleanroom operations, contamination control, or microbiological quality systems.
• Experience conducting Root Cause Analysis (RCA), implementing effective corrective and preventive actions, including CAPA, investigations, nonconformance management, deviations, and change control activities.
• Experience supporting internal audits, supplier audits, regulatory inspections, and external audits preferred.
• Experience utilizing statistical analysis and trending methodologies to evaluate process and environmental performance data.

Education:

• Bachelor’s degree in a health, Engineering or Science field is preferred.

• Sterilization Association certification or equivalent sterilization training preferred.

• ASQ or equivalent certification and/or relevant work experience is preferred. Other Professional certification is preferred (i.e. CQE, SQE, etc.)

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at [email protected]