Quality Engineering Specialist
Quality Engineering Specialist
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Not Disclosed
Salary Not Disclosed
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 atwww.coopersurgical.
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 CAPA Coordinator will be responsibleto administer Trumbull CAPA (Corrective and Preventive Action) System and ensure the timely and accurate completion of all CAPA activities. This individual will need to possess strong organizational problemsolving and communication skills.
Essential Functions & Accountabilities:
- Administer Trumbull site CAPA system.
- Works closely with other functional areas with the use of investigational tools to determine the root cause of any nonconformity ensures that CAPA plans address root causes and ensures that corrective actions and preventative actions are implemented to facilitate the rapid compliant introduction of new/improved products processes and systems.
- Responsible to ensure that actions are executed on time thorough complete meet the needs of the business and customers and that required standards and/or procedural requirements are met.
- Implement necessary followup verification/milestone checks on Corrective and Preventive Action items ensure timely followup and approval occur throughout term of the CAPA process.
- Facilitate crossfunctional meetings with internal and external parties as required.
- Responsible for maintaining CAPA tracking tools/databases. Responsible for sending periodic reminder notifications to CAPA owners.
- Maintains the effectiveness of the CAPA system records to ensure auditreadiness for internal and external quality system audits within the area.
- Ensures all CAPArelated documentation is managed in a complete clear concise and controlled manner.
- Support external and internal audits in CAPA related topics and any other Quality System task as per Management request.
- Continuously improve CAPA system procedure forms and any other related Quality System document.
- Serve as CAPA trainer for new current and new CAPA owners in the CAPA process and system.
Travel:
This position may require 5 domestic and international travel.
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Qualifications
- Bachelors degree in a health Engineering or Science field required.
- Minimum of 3 years of experience in medical device or healthcare industry related experience.
- Working knowledge of FDA regulations ISO 13485 MDSAP.
- 3 years working with CAPA Investigation Systems.
- External / Internal Audit experience.
- Strong knowledge of relevant quality standards and regulations including ISOCFR 820 MDSAP
- Proven experience in CAPA investigation Root Cause Analysis (Investigation Tools)
- Have strong written and verbal communication skills.
- Must be organized and able to prioritize duties and responsibilities.
- Must demonstrate initiative proactiveness innovation and analytical problemsolving skills.
- Able to interact with all levels and disciplines of employees.
- Must have attention to detail and multitasking ability.
- Strong communication and interpersonal skills
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 atwww.coopersurgicalto 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:
Unclear Seniority
Employment Type
Full-Time
