Quality Manager

About CooperSurgical

CooperSurgical is a leading fertility and womens healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to womens healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by womens health care clinicians. More information can be found at www.coopersurgical.com.

The Quality Manager is responsible for maintaining and leading the execution of the sites Quality Management System in compliance with applicable medical device regulations (such as ISO 13485, EU MDR, and 21 CFR Part 820) and internal standards. This role oversees or coordinates all quality system functions, including complaints, CAPAs, nonconformances, document control, and supplier management. Additionally, the Quality Manager leads operational quality activities such as lot release, production review, and coordination with contract manufacturing and sterilization partners. The position plays a key role in preparing for and hosting external audits and regulatory inspections while supporting the organizations integration with the parent company.

Essential Functions & Accountabilities:

• Serve as Management Representative for the sites Quality Management System
• Oversee or coordinate execution of core QMS processes:
  • CAPAs, Non-Conformances, Complaints
  • Supplier Management
  • Document Control and Change Control
  • Internal Audit Planning and Execution
  • Post-Market Surveillance and Medical Device Reporting
  • Management Review
  • Training Program Oversight
  • Maintenance of the Device Master Record (DMR)
• Prepare for, host, and respond to external audits and inspections
• Communicate with external regulatory bodies, EU Authorized Representative, and Importer
• Perform quality review of daily production and monthly lot release.
• Review supplier certificates and test reports for release, and maintain records
• Serve as primary site interface with contract manufacturer, coordinate notifications of monthly production, verify QMS and process documentation is current, Issue POs for product shipments
• Coordinate with sterilization vendor, issue monthly POs for sterilization and initiate test requests and POs for quarterly dose audits
• Manage product release testing: Coordinating samples to external labs, reviewing results, maintaining records
• Order materials and maintain label control
• Maintain environmental monitoring records
• Complete monthly cleaning and calibration documents
• Support integration activities and ensure continuity of QMS operations during transition
• As business needs dictate, work extended hours to complete daily department goals or tasks to include mandatory overtime
• Other duties as assigned

Travel: 

Up to 10% domestic travel may be required.

• Bachelors degree in life sciences, engineering, or related technical discipline

Preferred:

• Professional certifications (CQA, RAC, PMP)
• 5+ Years of experience in Quality Assurance within the medical device industry
• 2+ Years of experience overseeing QMS elements independently or in a lead role
• Experience hosting or significant contributions to support external audits

Preferred:

• Experience in a small company or startup-like environment
• Experience managing contract manufacturers or external suppliers
• Exposure to integration or acquisition-related quality transitions
• In-depth knowledge of ISO 13485, EU MDR, and FDA 21 CFR Part 820)
• Strong understanding of QMS processes including CAPA, complaints, audits, and supplier controls
• Demonstrated ability to prepare for and lead regulatory audits
• Excellent written and verbal communication skills, including interaction with external regulators and suppliers
• Strong organizational and project management skills
• Comfortable working in a small-site wearing multiple hats

Preferred:

• Experience working with gamma sterilization and dose audit programs
• Experience interfacing with EU Authorized Rep/Importer
• Familiarity with integration into larger corporate QMS structures
• Working knowledge of label control and environmental monitoring in a manufacturing setting

As an employee of CooperSurgical, youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

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.

Information :

• Company : CooperVision
• Position : Quality Manager
• Location : Rockville, MD
• Country : US