Sr. Quality Engineer

About CooperSurgical

JOB DESCRIPTION

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

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.

Qualifications

• 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 experience (NCMRs, CAPAs, Validations, Change Control, Training)
• Minimum 10 years of experience managing external audits.
• At least 10 years’ experience in Quality Management/Quality Systems/ Audit Program Management
• Experience in integrations/acquisitions with respect to ensuring quality requirements are preserved pre-post integration.
  
  
  

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.