Quality Engineer II
Quality Engineer II
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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
To perform this job successfully an individual must be able to execute each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must have strong working knowledge in:
- 21CFR820 ISO13485:2016 ISO14971
- Process validation (IQ/OQ/PQ/TMV/MSA)
- Experience in integrations/acquisitions with respect to ensuring quality requirements are preserved prepost integration.
- Presentation of results in a logical and clear manner
- 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.
- Travel up to 25
Qualifications
- BS Degree in Life Science Engineering or equivalent program is preferred
- At least 2 years of experience in the medical device industry
- Ideally both in transferring/scaling up existing processes as well as developing new processes
- NCMR CAPA Change control and GDP experience
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.
Employment Type
Full-Time
