Quality Engineering Jobs

Quality Engineering

CooperSurgical, Inc.

Trumbull, CT

Position Summary:

A Quality Engineer is responsible for executing on projects to improve and maintain the state of effectiveness of the QMS. These responsibilities include investigation of NCMR/CAPAs, writing reviewing and executing process validations, and ensuring product requirements are being met through the design of the process.

Specifically for this position, we are looking for a quality engineer with experience in transferring existing manufacturing lines from one location to another, as well as experience with active medical devices (electronics/software based capital equipment). The qualified candidate for this position would Participate on the project team as a subject matter expert in the area of process design/qualification (Process map, PFMEA, Process Validation, Control plans, etc.)

Essential Functions:

To perform this job successfully, an individual must be able to execute each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Background in statistics with respect to process control (reliability, capability, SPC, etc.)
• Ability to communicate effectively both orally and in writing
• BS Degree in Life Science, Engineering or equivalent program is preferred
• Ability to analyze information and come to conclusions based on presented data
• NCMR, CAPA, Change control and GDP experience
• Ability to learn and utilize computer in standard business applications including electronic document control, word processing, spreadsheets and databases.
• Strong organizational and interpersonal skills
• Experience in integrations/acquisitions with respect to ensuring quality requirements are preserved pre-post integration.
• Must have strong working knowledge in:
• 21CFR820, ISO13485:2016, ISO14971
• Process validation (IQ/OQ/PQ/TMV/MSA)
• Presentation of results in a logical and clear manner
• Ideally both in transferring/scaling up existing processes as well as developing new processes
• Travel up to 25%
• At least 5 years of experience in the medical device industry

About CooperSurgical:

CooperSurgical is a leader in manufacturing and marketing multiple trusted and innovative brands that assist clinicians in improving the health of women, babies and families worldwide. Through an aggressive growth and diversification strategy, CooperSurgical has evolved its portfolio of over 600 products to include products and services used primarily by obstetricians and gynecologists in surgical and medical procedures wherever they occur: in hospitals, surgical centers, medical offices and fertility clinics.

Our Benefits:

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.