Cooper Companies
Quality Engineer II
Cooper Companies, North Tonawanda, NY, United States
Job Description
The responsibility of a Quality Engineer is to ensure 21 CFR part 211 Compliance among all areas in the manufacturing process. In this role, the Quality Engineer will be responsible for quality oversight of the manufacturing facility via closure and monitoring of internal investigations, risk management, CAPA coordination and effectiveness, validation efforts, and QA projects in North Tonawanda, NY.
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
Qualifications
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.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $67,000 - $112,000. The actual base pay includes many factors, and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.
The responsibility of a Quality Engineer is to ensure 21 CFR part 211 Compliance among all areas in the manufacturing process. In this role, the Quality Engineer will be responsible for quality oversight of the manufacturing facility via closure and monitoring of internal investigations, risk management, CAPA coordination and effectiveness, validation efforts, and QA projects in North Tonawanda, NY.
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
- 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 follow-up verification/milestone checks on Corrective and Preventive Action items, ensure timely follow-up and approval occur throughout term of the CAPA process.
- Facilitate cross-functional 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 audit-readiness for internal and external quality system audits within the area.
- Ensures all CAPA-related 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 QMS systems, procedures, forms and any other related Quality System document.
- Travel as needed for training, auditing or other activities.
Qualifications
- Working knowledge of FDA regulations pertaining to 21 CFR Parts 211 & 820
- 2+ years working with CAPA Investigation Systems.
- Proven experience in CAPA investigations, Root Cause Analysis (Investigation Tools)
- Strong written and verbal communication skills.
- Strong problem-solving skills with the ability to drive positive process improvements within the organization
- Must be organized and able to prioritize duties and responsibilities.
- Must demonstrate initiative, proactiveness, innovation, and analytical problem-solving skills.
- Able to interact with all levels and disciplines of employees.
- Must have attention to detail and multi-tasking ability.
- Strong communication and interpersonal skills
- External / Internal Audit experience desirable.
- Light lifting
- Prolonged sitting in front of computer
- Prolonged standing on operational floor
- Minimum of 2 years of experience working in manufacturing environment preferably within a pharmaceutical or medical devices related field
- Bachelor's degree in a Health, Engineering or Science preferred or equivalent work experience.
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.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $67,000 - $112,000. The actual base pay includes many factors, and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.