Sr Quality Engineer
Sr Quality Engineer
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1 Vacancy
Job Description
About CooperSurgical
CooperSurgical is a leading fertility and womens 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 womens healthcare providers including testing and treatment options.
CooperSurgical is a whollyowned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical headquartered in Trumbull CT produces and markets a wide array of products and services for use by womens health care clinicians. More information can be found at.
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 companys 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 selfdetecting and selfcorrecting 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 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 .
Travel:
This position may require 1020 domestic and international travel.
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Qualifications
- Bachelors 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 prepost integration.
As an employee of CooperSurgical youll 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 atto 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 viaemail 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.
Required Experience:
Senior IC
Employment Type
Full-Time
