The Plant Quality Manager will be accountable to ensure the Quality Management System is implemented per requirements and to report areas of concern to Management. The Plant Quality Manager will be expected to ensure the plant remains in full compliance will regulatory requirements and ISO:13485 requirements as they pertain to the plant, customer specifications, and corporate quality procedures. This role will also be responsible for managing Quality department personnel at the site, including Quality Lab, Supplier Quality, Quality Engineering, and Site Cleanroom Monitoring and Control.
Promotes a safe working environment, complies with proper use of PPE, reports incidents, and participates in functional department safety meetings. Exhibits good environmental practices and procedures consistent with job(s) performed and EMS (Environmental Management System) requirements (ISO14644).
Job Functions:
Execution and oversight of a Quality Management System that operates in compliance with corporate quality policies and procedures, as well as relevant regulatory requirements (ISO:13485) and industry guidance.
Execution of document control and review/approval of controlled documents.
Execution and maintenance of ECO process including change management and review of all change controls.
Execution and maintenance of supplier quality management and performance of supplier audits as appropriate.
Complaint management including robust root cause analysis and CAPA.
Ensure robust root cause analysis investigation and CAPA for deviations and nonconforming product.
Implementation of an effective Internal Audit Program.
Ensure adequate training program is in place.
Oversight of applicable Validation Master Plan including equipment, process, product, sterilization, and test methods.
Oversight of quality control laboratory and review/approval of quality control testing.
Execution of cleanroom practices including qualification, monitoring, and behavior.
Responsible for maintenance and expansion of the Global QMS e-tool (ETQ) at the plant.
Facilitate management review process including implementation of a metrics control plan to measure and monitor the health of the Quality Management System, Manufacturing System, and Supply Chain.
Oversight and Maintenance of Site Sterility Program
Customer Management including facilitating/hosting customer audits, ensuring robust and effective corrective action to customer audit observations, reviewing/approving quality agreements with customers, partnering in the resolution of quality issues and requests for information by initiating effective interdepartmental communication, managing ISO certification and maintenance of certification.
Execute talent management activities with direct reports. Ensure proper performance management, training, and development of direct/indirect reports
Minimum Bachelor's Degree in Engineering-Preferred, or Life Sciences-related field (Chemistry, Biology, or Microbiology); required.
Master's Degree in MBA or equivalent; preferred.
ASQ Certifications desirable (CQE, CQM, CQA); preferred.
ISO 13485 or Medical device experience; required.
Minimum of 5 years of experience in a regulated industry with emphasis in life sciences (e.g., pharma, biopharm, or medical device); required.
Minimum of 6 years in a Quality function with at least 3 years in a Quality System development and implementation role; required.
At least 3 years in a direct supervisory role; preferred.
Must be independent, quality, and cost-conscious, with skills in leadership and team building; required.
Must have experience in performing risk analysis (e.g., FMEA, FTA, Risk Ranking/Filtering); required.
Employees have the flexibility to choose the benefits that best fit their individual needs.
Health and Wellbeing - Supporting your wellbeing, to thrive in life and work.
Medical, Prescription Drug, Vision, and Dental Insurance
Healthcare Saving Account and Flexible Spending Account options
LiveWell Wellness Program
Employee Assistance Program (EAP)
Paid Time Off and Paid Parental Leave
Retirement and Protection - Helping to make the future life you want a reality.
401(k) with Company Match, Retirement Accumulation Plan (RAP), Cash Balance Pension Plan
Company-provided Life Insurance, AD&D, Short-Term Disability
Voluntary employee and dependent life insurance, Long-Term Disability, Critical Illness and Accident Insurance
Additional Benefits - Helping shape the experience and impact you want
Commuter Benefits
Group Legal
Identity Theft Protection
Auto and Home Insurance
Pet Insurance and Discounts
Back-up Child & Elder Care
PerkSpot Employee Discount Program
Saint-Gobain's innovations touch almost every major industry around the world. Within its Life Sciences division, teams are solving critical problems for customers who are getting life-saving medical devices to the frontlines of healthcare, discovering essential medications, and nourishing and connecting the world through consumer, industrial and electronics applications. As one of the world's leading producers of high-performance polymer products, we improve lives by making simple experiences better and being there in life's critical moments.
Our team members recognize that we all create the environment for people to succeed, with a culture built on respect, open and honest communication, and honoring our commitments to our customers and each other. And at the heart of our culture, we've learned working together makes good ideas, great ones.
With a legacy dating back more than 350 years, Saint-Gobain offers employees the stability and security of a leading Global 500 corporation while operating like multiple small and agile start-ups, where entrepreneurial spirit, pioneering teamwork, and bold, forward-thinking ideas pave new paths.
Every team member is encouraged to develop and leverage their unique expertise and strengths to make the greatest impact on the company and our end users. At Saint-Gobain, you're empowered and equipped with countless opportunities and resources for professional development. You will find the support you need to create a vision and roadmap for your career, and make that vision a reality.
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Join Us at Saint-Gobain Life Sciences. Together, we'll create a better life.
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