Quality Engineering Specialist

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 Quality Engineering Specialist supports the implementation and maintenance of the site Quality Management System (QMS) at the North Tonawanda NY facility to ensure compliance with applicable FDA regulations and current Good Manufacturing Practices (cGMP) including 21 CFR Parts 210 211 and 820. This includes supporting quality system activities related to internal investigations CAPA Change Control documentation control and continuous improvement and interfacing crossfunctionally with Manufacturing Engineering Validation Regulatory and Quality to support compliant operations timely issue resolutions and inspection readiness.

Job Summary:

The Quality Engineering Specialist is responsible for facilitating regulatory compliance at the North Tonawanda NY facility pertaining to 21 CFR parts 210 211 and 820 as well as the closure and monitoring of internal investigations contributing to efficacy of the sites Quality Management System (QMS) as needed. The Quality Engineering Specialist contributes to maintaining product quality regulatory compliance and data integrity while developing technical and regulatory proficiency within a regulated manufacturing environment.

• Support the implementation and maintenance of riskbased quality processes to ensure compliance with 21 CFR Parts 210 and 211 under the guidance of senior quality staff.
• Assist in the development implementation and maintenance of the site Quality Management System (QMS) in accordance with cGMP requirements FDA regulations and internal procedures.
• Execute internal investigations related to deviations environmental excursions outofspecification (OOS) and outoftrend (OOT) events in a timely and compliant manner with appropriate oversight.
• Apply structured root cause analysis tools to support identification of contributing and root causes of nonconformances.
• Support the development and tracking of Corrective and Preventive Actions (CAPAs) including documentation and effectiveness checks to ensure resolution of quality issues.

• Support the site Change Control process by reviewing change requests for completeness accuracy and compliance with cGMP requirements and by assisting in impact assessments documentation and timely closure under the guidance of senior quality staff.

• Collaborate with crossfunctional teams (Manufacturing Engineering Validation Regulatory and Quality) to support the execution and timely closure of investigations corrective actions and Change Control activities in accordance with cGMP requirements.

• Ensure quality documentation is accurate complete and compliant with cGMP documentation practices.
• Participate in quality meetings and forums to communicate investigation status and support continuous improvement initiatives.
• Provide support during internal customer and regulatory audits including document preparation and response support.
• Contribute to continuous improvement activities related to QMS processes procedures and quality systems.
• Perform other duties as assigned.

Travel:this position may require 10-20% domestic and/or international travel.

Knowledge Skills and Abilities:

• Foundational knowledge of FDA regulations and current Good Manufacturing Practices (cGMP) including 21 CFR Parts 210 and 211 applicable to pharmaceutical manufacturing environments.
• Basic understanding of Quality Management System (QMS) elements including deviations CAPA Change Control and documentation control.
• Experience supporting or executing quality investigations (e.g. deviations environmental excursions outofspecification (OOS) and outoftrend (OOT) events) in a regulated environment with guidance from senior quality staff.
• Familiarity with root cause analysis and analytical problemsolving tools used to support identification of contributing and root causes of quality events.
• Ability to support the documentation tracking and effectiveness verification of CAPAs to ensure timely and compliant resolution of quality issues.
• Working knowledge of Change Control processes including review of change requests for completeness and accuracy and support of impact assessments documentation and timely closure.
• Demonstrated ability to generate and maintain accurate complete and compliant cGMP documentation with strong attention to detail and data integrity.
• Strong written and verbal communication skills with the ability to clearly document quality activities and communicate effectively with crossfunctional stakeholders.
• Strong interpersonal skills and ability to interact effectively with employees at all levels and across multiple disciplines.
• Strong organizational and timemanagement skills including the ability to prioritize duties manage multiple tasks and meet established timelines in a regulated environment.
• Demonstrated initiative proactiveness and analytical problemsolving ability with the capability to identify opportunities for positive process and quality system improvements.
• Ability to support internal customer and regulatory audits including document preparation and response.
• Willingness to learn follow established procedures and contribute to continuous improvement initiatives related to QMS processes procedures and quality systems.

Work Environment:

• Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting standing or getting up and down throughout the day.
• Occasionally lift to 35 pounds.
• 3 years experience working in manufacturing environment preferably within pharmaceutical or medical device related field.

Experience:

Education:

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

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.