Senior Manager, Quality Assurance Management

Description

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 .

Responsibilities

Serve as the Site Head of QA and the management representative for the Trumbull CT site.

Work with senior leadership to develop and maintain a site QA organizational structure aligned with the global quality strategy.

Lead strategic planning direction and goal setting for site QA team.

Instill a culture of continuous quality improvement by developing and implementing strategies that achieve measurable results.

Manage hire train evaluate and provide guidance and coaching to site QA personnel.

Serve as the quality representative for site leadership and cross-functional teams.

Ensure site compliance with 21 CFR 820 ISO 13485 EU MDR MDSAP and other applicable regulations.

Lead site readiness and response and serve as the host for regulatory inspections internal and external audits.

Oversee and as needed participate in day-to-day QA activities including DHR review and approval NCMR CAPA document control product release and ECN processes.

Collaborate with manufacturing engineering and R&D to resolve quality issues and improve processes.

Monitor and report on key quality metrics and trends.

Host periodic management review meetings.

Participate in other projects as directed by senior and executive leadership.

Perform other duties as assigned.

Qualifications

Proven leadership experience managing QA teams and site-level quality operations.

In-depth knowledge of 21 CFR 820 ISO 13485 EU MDR MDSAP and other global standards.

Ability to work in a matrixed organization developing strong relationships with all levels of staff and management partnering across multidisciplinary teams (internal / external).

Strong situational analysis and judgement able to provide guidance and counsel to site and staff throughout organization.

Strong time management skills as an individual contributor and as a leader able to drive individual / team projects to scheduled completion on time.

Excellent team building and leadership skills able to motivate team members to drive projects to successful completion with the ability to manage and lead without direct daily input from senior leadership.

Strong organizational interpersonal verbal and written communication skills (clear concise effective with a variety of stakeholders).

Strong data analysis negotiation and problem-solving skills.

Must be proficient in the use of Microsoft Excel Microsoft Word Outlook and PowerPoint.

Experience in hosting regulatory audits / inspections is required.

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 at 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. If you are interested in applying and require special assistance or accommodations due to a disability please contact us at

Required Experience :

Senior Manager

Key Skills

Continuous Integration,Quality Assurance,FDA Regulations,Root cause Analysis,TFS,Food Processing,ICH Q10,Jira,Software Testing,Quality Management,Selenium,Github

Employment Type : Full-Time

Experience : years

Vacancy : 1