Quality Engineer II

1 month ago

Stafford, United States Cooper Companies Full time
Job Description

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.

Responsibilities

This role will have responsibility for various products throughout the manufacturing facility, working with cross-functional teams to ensure product quality. Quality Engineer will support QA in all areas from start to finish of new projects that require QA inspection / testing / CIP support for increased output and QA projects for R&D in Stafford, TX.

Essential Functions & Accountabilities:

Role responsibilities summarized below:
  • 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.
  • Improve and maintain data, accuracy, quality of labels and labeling process and with new QA projects
  • 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
  • CAPA - Responsible for overseeing assigned CAPA's, perform to CAPA KPIs, track and trend, and provide summaries with improvements to management.
  • IQAs- Perform IQA audits and support other auditors. Responsible for scheduling and conducting IQAs, perform to IQA KPIs, and provide track and trend summaries with improvements to management.
  • Perform Risk Analysis and manage Risk Mitigations for raw material and components made for Trumbull/CR.
  • Review incoming inspection instructions and make recommendations as needed.
  • Coordinate component Inspection Sampling for incoming parts.
  • Perform/complete PFMEA's and generate/improve internal Control Plans.
  • Provide support for MDR transition activities and EMCP activities, create, control and adhere to SOPs.
  • Understanding of GD&T.
  • Performs other duties as directed by management.
Travel: 5-10% between facilities

#LI-DD1

Qualifications
  • Minimum 3-4 years' work experience in quality, manufacturing, or engineering with proven track record in CIP, IQA and CAPA processes
  • Bachelor's degree in Engineering
  • Green Belt or Black Belt skills a plus.
  • Statistical Analysis ability (8D, Fishbone, 5 Whys).
  • Ability to perform Root Cause Analysis (8D, Fishbone, 5 Whys).
  • A general understanding of Lean practices in the manufacturing environment.
  • Quality Certification a plus.
  • 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 results orientation.
  • Comfortable with complex technical analysis.
  • Passing of background check, which may include verification of prior employment, criminal conviction history, educational 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.

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