Quality Engineer I

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. As a division of CooperCompanies were driven by a unified purpose to enable patients to experience lifes beautiful moments. Guided by our shared values dedicated innovative friendly partners and do the right thing our offerings support patients throughout their lifetimes from contraception to fertility and birth solutions to womens and family care and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers including testing and treatment options as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at.

Work location: North Tonawanda NY (on-site)

Scope:

The responsibility of a Quality Engineer is to ensure 21 CFR parts 210 211 and 820 Compliance among within the manufacturing process.

Job Summary:

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 responsibility of the Quality Engineer I is to facilitate regulatory compliance at the North Tonawanda NY facility pertaining to 21 CFR parts 210 211 and 820. In this role the Quality Engineer I will be primarily responsible for the closure and monitoring of internal investigations related to product complaints as well as contributing to efficacy of the sites Quality Management System (QMS) as needed.

• Assist in the development implementation and maintenance of the companys QMS in accordance with cGMP and regulatory requirements.
• Responsible for the site level intake and triage of product complaints based on initial risk findings and pre-defined standards as well as the assessment and escalation of high-risk product complaints.
• Work closely with cross functional teams with the use of investigational tools to determine the root cause of any product nonconformity to ensure that CAPA plans address root cause(s) and that corrective actions and preventative actions are implemented to facilitate the rapid compliant introduction of new/improved products processes and systems.
• Ensures all site documentation is managed in a complete clear concise and controlled manner.
• Participate in cross-functional meetings with internal and external parties as required.
• Support internal and external audits as needed.
• Contribute to the continuous improvement of QMS systems procedures forms and any other related Quality System document.

Travel:

• Travel as needed for training auditing or other activities (5-10%).

• Working knowledge of FDA regulations pertaining to 21 CFR Parts 210 211 & 820
• Proven experience in assisting in product complaint and CAPA investigations. Root Cause Analysis (Investigation Tools) experience desired
• 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

Work Environment:

• Light lifting

• Prolonged sitting in front of computer

• Prolonged standing on operational floor

Experience:

• Minimum of 2 years of experience working in manufacturing environment preferably within a pharmaceutical or medical devices related field

Education:

• Bachelors degree in a Health Engineering or Science preferred or equivalent work experience.

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Our Benefits:

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 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 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 payfor this role is between$70000.00 - $90000.00 annually. Theactual base payincludes 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.