Complaints/CAPA investigator

Complaints/CAPA investigator

CooperSurgical Inc.

Stafford, TX

Position Summary:

The responsibility of a Quality Engineer is to ensure a constant compliance with all areas in the manufacturing process. In this role, the Quality Engineer will be responsible for quality oversight of the manufacturing facility via closure and monitoring of complaints investigation, risk management, CAPA coordination and effectiveness, validation efforts, and QA projects in Stafford, TX.

Essential Functions:

• Perform timely and effective closures of complaint investigations.
• Monitor and create, as appropriate, procedures 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.
• 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 and coordination of site CAPA’s, update 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.
• 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 managemen

Quality Engineer Education Required:

• Bachelor’s degree in Engineering or equivalent

Qualifications:

• Minimum 1-2 years work experience in quality, manufacturing, or engineering
• Green Belt or Black Belt skills a plus.
• Statistical Analysis ability
• Ability to perform Root Cause Analysis (8D, Fishbone, 5 Whys).
• A general understanding of Lean practices in 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 a results orientation.
• Comfortable with complex technical analysis.
• Ability to travel approximately 5-10% of the time.
• Passing of background check, which may include verification of prior employment, criminal conviction history, educational and driving records.