Sr. Quality Engineer

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.

CSI believes the quality, safety, and efficacy of our products are of the utmost importance to ensure we deliver impactful solutions that improve healthcare. The Senior Quality Engineering will be responsible for ensuring the highest standards of quality throughout our organization. This position requires a strategic thinker with a deep understanding of quality management systems, change control processes, and a proven track record of implementing and maintaining robust quality processes.

 

Essential Functions & Accountabilities:

· Development, implement, and maintain the company's QMS in accordance with relevant industry standards and regulations.

· Analyzing quality data and generating reports to assess the performance of the quality management system and identify trends or areas for improvement.

· Guide/Lead Quality Engineers as they continuously improve the manufacturing plant processes and procedures to meet Quality, Compliance and Business objectives.

· This individual will be viewed as a senior level technical expert, who will coach and mentor more junior level employees

· Trend Monthly Quality data (NCMR, CAPA, etc.) to ensure quality resources are being properly deployed to address the needs of the business. Ability to present results in logical manner

· Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability

· Coordinate and support Manufacturing Process Validation (VMP, IQ, OQ, PQ) to make sure that all validation activities are in accordance with ISO 13485:2016, FDA 21 CFR Part 820, MDSAP and other applicable regulations.

· Coordinate the execution of Measurement System Analysis Validations (MSA), as per business needs.

· Support Validation activities during acquisition and transfer projects, as per site business needs.

· Develop Process Failure Mode and Effect Analysis (pFMEA) to manage process risks.

· Collaborate with teams to investigate and resolve quality issues, implement corrective actions to prevent recurrence, and verify effectiveness of actions.

· Implement Lean and Six Sigma methodologies to streamline processes and reduce nonconformities.

· Creating, approving procedures and investigations to continuously improve site Quality Management System.

· Monitor and communicate status of site KPI metrics for NCMRs, CAPA, and other QMS processes to the management.

· Ability to analyze information and come to conclusions based on presented data

· Ability to communicate effectively both orally and in writing

· Strong organizational and interpersonal skills

· Ability to learn and utilize computer in standard business applications including electronic document control, word processing, spreadsheets, and databases.

· Background in statistics with respect to process control (reliability, capability, SPC, etc.)

· Active role in supporting external audits preparation and execution.

Travel:

This position may require 10-20% domestic and international travel.

 

#LI-DD1

• Bachelor’s degree in a health, Engineering or Science field required; Advanced degree preferred.
• · Certified Lead Auditor ISO 13485:2016) is preferred.
• · ASQ or equivalent certification and/or relevant work experience is highly preferred. Other Professional certification is an advantage (i.e, CQA, CQE, SQE, CQM, Etc)
• · Must have strong knowledge in:
• o Process validation (IQ/OQ/PQ/TMV/MSA)
• o Ideally both in transferring/scaling up existing processes as well as developing new processes
• o NCMR, CAPA, Change control and GDP experience
• · Minimum of 10 years of experience in medical device or healthcare industry related experience.
• · 10+ years of quality systems background