Quality Engineering Generalist

About CooperSurgical

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. 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 women's 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 women's health care clinicians. More information can be found at www.coopersurgical.com.

• Full knowledge of and understanding of 8D and other Quality Tools.

• Full knowledge of Excel and ability to capture and create charts and report

• Knowledge and full understanding of the medical device requirements (e.g., FDA QSR, ISO 13485, EU MDR, CMDCAS and etc..).

• Works with Value Streams once Engineering and Quality Engineering; confirm there is a Supplier related improvement opportunity or Non-Conforming Material Reports (NCMRs).
  3.Supports development and implementation of supplier quality program by doing the following:

a. Support supplier on-going monitoring and re-evaluation process.

b. Manage Supplier SCAR / CAPA / NCR and periodically provide metrics/report to Management Review Process.

Files and maintains Supplier related documentation as per QMS.

• Works and leads collaborative activities with Quality Engineers, Inspectors, Value Streams as well as Purchasing, Engineering teams.

• When required, submits Supplier Corrective Action Requests (SCAR) for Supplier related NCMRs. And reviews Supplier responses for appropriate root cause analysis and Corrective Actions to prevent re-occurrence of failure modes.

• Performs additional assignments as required by management.

• Create a critical review of supplier strategies and segmentation strategies.

• Bachelor's degree / Master's degree

• Certified Quality Engineer, Certified Reliability Engineer a plus

• Minimum 3 to 5 years of related experience.

• 3 to 7 years in regulated quality environment.

• Evaluate and provide input into Risk Management processes both internal and external

• Working knowledge of SCAR's, CAPA,

• Perform and drive Supplier Development activities and improvements.

• Execution and driver of results as a team lead and as an active participant

• Able to define, implement and manage a nonconformance system.

• Fully understand 8-D process and have the ability .

• Full understanding and application of FDA QSR, ISO 13485, and other applicable regulations

• Working knowledge of Dfx, Risk Management, and Data Analysis

• Working knowledge and ability to properly problem solve utilizing the appropriate Quality Tools

• Effectively evaluate drawings and provide improvements and recommendations if necessary (e.g., dimensions, tolerances, notes, and etc.)

• Previous experience in supply chain, auditing, verification, and validation, GD&T.

• Previous experience with Change Control Systems and Design Control.

• Excellent verbal and written communication skills and strong organizational skills

• Advance level of English speaking and writing.

• Computer skills, MS Office, Minitab, and previous experience with ERP and QMS systems.

• Passing of background check, which may include verification of prior employment, criminal conviction history, education and driving records.

As an employee of CooperSurgical, you'll 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.