Quality Engineer II - Manufacturing, Life Sciences - Akron, OH - Saint-Gobain
AKRON, OH
About the Job
If you want to reshape the world and discover your greatest potential, Saint-Gobain provides one-of-a-kind opportunities for innovative problem solvers.
We're one of only two companies in the world that is consistently recognized as both a top Global Employer and a Top 100 Global Innovator, but Saint-Gobain's remarkable story and culture of innovation begins with a team of nearly 200,000 creative, diverse and passionate team members collaborating across the globe. We are committed to our mission to improve lives because, every day, we witness the enormous impact of our efforts on the world around us.
The Quality Engineer II will support the Quality Manager to ensure that the Quality Management System and quality standards of the company are implemented and maintained at the Saint Gobain Life Sciences Akron facility in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations.
Key Accountabilities
Manage 3 Quality Technicians on 3 different shifts
Lead and/or support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including:
- Document control and review/approval of controlled documents
- Change management and review of change controls
- Investigation and CAPA management, including robust root cause analysis
- Complaint management and performance of complaint investigations
- Supplier quality management and performance of supplier audits as appropriate
- Internal audit program and performance of internal audits
- Training program; conduct training when needed
- Implementation of Quality Risk Management in relevant aspects of the QMS
- Management Review
- ISO certification and maintenance
Lead and/or support the oversight of product realization and commercial manufacturing activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management.
Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product.
Customer support, including:
- Support customer audits, including response and corrective action tracking
- Partner in the resolution of quality issues and customer requests by initiating effective interdepartmental communication.
-
Education:
Bachelor's degree in Life Sciences or Engineering - REQUIRED
License/Certification:
ASQ certifications (CQE, CQM, CQA) - PREFERRED
Work Experience:
5+ years of experience working Regulated industry, such as life sciences, food and beverage, or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device). - REQUIRED
5+ years Experience working in a quality role (QMS development, implementation, and/or execution) within a manufacturing environment.)-REQUIRED
2+ years of supervisory or management position - REQUIRED-
General Skills/Competencies Required:
Strong knowledge of ISO and cGMP requirements and relevant industry standard practices. Must have ability to interpret these regulations to ensure proper implementation in the plant systems. - REQUIRED
Strong knowledge of quality systems and product/process lifecycle management within a manufacturing environment - REQUIRED
Proficient computer skills required including Microsoft Access, Excel and Word. - REQUIRED
Digital solution development skills and understanding of systems, data integrity and data creation
Leadership & communication skills:
Proven ability to work well in a team environment and model to others essential behaviors, such as initiative, ownership, organizational accountability, and change management. Ability to lead investigations and projects. - REQUIRED
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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.
Invent yourself at Saint-Gobain Life Sciences; and together, we’ll create a better life.
Click here to Explore more opportunities within Saint-Gobain Life Sciences. (https://careers.saint-gobain-northamerica.com/career-search/?pg=1&search=Life%20Sciences)
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Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Saint-Gobain is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.
We're one of only two companies in the world that is consistently recognized as both a top Global Employer and a Top 100 Global Innovator, but Saint-Gobain's remarkable story and culture of innovation begins with a team of nearly 200,000 creative, diverse and passionate team members collaborating across the globe. We are committed to our mission to improve lives because, every day, we witness the enormous impact of our efforts on the world around us.
The Quality Engineer II will support the Quality Manager to ensure that the Quality Management System and quality standards of the company are implemented and maintained at the Saint Gobain Life Sciences Akron facility in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations.
Key Accountabilities
Manage 3 Quality Technicians on 3 different shifts
Lead and/or support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including:
- Document control and review/approval of controlled documents
- Change management and review of change controls
- Investigation and CAPA management, including robust root cause analysis
- Complaint management and performance of complaint investigations
- Supplier quality management and performance of supplier audits as appropriate
- Internal audit program and performance of internal audits
- Training program; conduct training when needed
- Implementation of Quality Risk Management in relevant aspects of the QMS
- Management Review
- ISO certification and maintenance
Lead and/or support the oversight of product realization and commercial manufacturing activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management.
Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product.
Customer support, including:
- Support customer audits, including response and corrective action tracking
- Partner in the resolution of quality issues and customer requests by initiating effective interdepartmental communication.
-
Education:
Bachelor's degree in Life Sciences or Engineering - REQUIRED
License/Certification:
ASQ certifications (CQE, CQM, CQA) - PREFERRED
Work Experience:
5+ years of experience working Regulated industry, such as life sciences, food and beverage, or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device). - REQUIRED
5+ years Experience working in a quality role (QMS development, implementation, and/or execution) within a manufacturing environment.)-REQUIRED
2+ years of supervisory or management position - REQUIRED-
General Skills/Competencies Required:
Strong knowledge of ISO and cGMP requirements and relevant industry standard practices. Must have ability to interpret these regulations to ensure proper implementation in the plant systems. - REQUIRED
Strong knowledge of quality systems and product/process lifecycle management within a manufacturing environment - REQUIRED
Proficient computer skills required including Microsoft Access, Excel and Word. - REQUIRED
Digital solution development skills and understanding of systems, data integrity and data creation
Leadership & communication skills:
Proven ability to work well in a team environment and model to others essential behaviors, such as initiative, ownership, organizational accountability, and change management. Ability to lead investigations and projects. - 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.
Invent yourself at Saint-Gobain Life Sciences; and together, we’ll create a better life.
Click here to Explore more opportunities within Saint-Gobain Life Sciences. (https://careers.saint-gobain-northamerica.com/career-search/?pg=1&search=Life%20Sciences)
-
-
Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Saint-Gobain is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.
Source : Saint-Gobain