Quality Engineering Specialist

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. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to 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.

Essential Functions & Accountabilities:

• Perform QA process Improvements to ensure effective and efficient process flow, training, etc. for new projects and help improve existing QA projects. Recommend, innovate and implement revised methods and processes. 
• Responsible for creating new procedures related to metrology.
• Validation- review and approve manufacturing validations (IQ, OQ, PQ) for new products and carry out QA validations.
• Nonconforming Material – drive closure of NCMR’s, improve processes to reduce/mitigate NCs, and provide trend reports to management
• Assist in CAPA closures, including track and trend, provide status updates with respect action items identified within the investigation. 
• Assists in execution of internal and supplier audits.
• Perform Risk Analysis and manage Risk Mitigations for raw material and components made for customers.
• Review incoming inspection instructions and make recommendations as needed.
• Assists and provide technical assistance
• Perform/complete PFMEA’s and generate/improve internal Control Plans.
• Performs cross functional tasks until appropriate resources are in place, or as directed by management.

Travel:

• Ability to travel approximately 5-10% of the time.

Qualifications

Knowledge, Skills and Abilities:

• Minimum 2-3 years work experience in quality, manufacturing, or engineering with proven track record in CIP, IQA and CAPA processes. 
• Passing of background check, which may include verification of prior employment, criminal conviction history, educational and driving records.
• Green Belt or Black Belt skills a plus.
• Understanding in GD&T
• Statistical Analysis ability (MSA, normality test, confidence/reliability)
• Ability to perform Root Cause Analysis (8D, Fishbone, 5 Whys).
• A general understanding of Lean practices in manufacturing environment.
• Proven ability to manage multiple projects and tasks.
• Effective written and verbal communication skills.
• Proficient interpersonal skills and the ability to work effectively in a cross-functional team.
• Proficient in using Microsoft Office Suite Software.
• Creative problem-solving ability and result oriented.
• Comfortable with complex technical analysis.

Experience:

• Minimum 2-3 years work experience in quality, manufacturing, or engineering with proven track record in CIP, IQA and CAPA processes. 

Education:

• Bachelor’s degree in Engineering or equivalent
• Quality Certification a plus.

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 fir