Process Improvement Lead

4 days ago

Stafford, Texas, United States Cooper Companies Full time

About Cooper Companies

Cooper Companies is a leading global medical device company committed to delivering innovative solutions for women's health and fertility.

The Position

This role 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. The Quality Engineer will be responsible for ensuring product quality throughout the manufacturing facility, working with cross-functional teams.

Responsibilities:

  • Perform process improvements to ensure effective and efficient process flow, training, etc. for new projects and help improve existing QA projects.
  • 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.
  • IQA - 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.

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.

About Total Compensation

We offer an estimated salary range of $90,000-$110,000 per year, along with an outstanding total compensation plan including medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.

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