Quality Engineer - Manufacturing Life Sciences, Akron, OH
AKRON, Ohio
Employer: Saint Gobain
Industry: Technique-Production
Salary: Competitive
Job type: Full-Time
Pourquoi a-t-on besoin de vous ?
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.
JOB SUMMARY AND PURPOSE
The Quality Engineer I will support the Quality Manager to ensure that the Quality Management System and quality standards of the company are implemented and maintained at the Akron facility in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations.
ESSENTIAL FUNCTIONS AND RELATED OBJECTIVES:
• 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:
o Change management and review of change controls
o Investigation and CAPA management, including robust root cause analysis
o Complaint management and performance of complaint investigations
o Internal audit program and performance of internal audits
o Training program; conduct training when needed
o Preparation of Management Review materials/metrics
o ISO certification and maintenance 60%
• Support the oversight of product realization and commercial manufacturing activities, such as product/specification development, process capability, facilities/utilities/equipment qualification and maintenance, and materials management. 30%
• Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product. 20%
• Customer support, including:
o Support customer audits
o Product stewardship requests
Ce poste est-il fait pour vous ?
Education:
Bachelor's Degree - Life Sciences or Engineering discipline - REQUIRED
Licenses and Certifications:
ASQ certifications (e.g. CQE, CQM, CQA) 3 Years - Preferred
Work Experience:
3+ years - 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
1 year - Quality role (Quality System development, implementation, and/or execution) within a manufacturing environment - REQUIRED
Employee is responsible to:
• Know and understand the quality and safety policies.
• Complete all quality and safety training required for the specific position.
• Follow all quality and safety rules and procedures and remind others through coaching and leading by example.
• Commit to addressing and reporting any unsafe condition or quality issue immediately.
• Be empowered and speak up when unsafe behaviors are observed or quality issues arise and to not place blame while investigating these issues.
• Adhere to the principles of data integrity.
On vous en dit plus sur nous
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
Pour être sûr de ne rien oublier
Saint-Gobain's innovations touch almost every major industry around the world, Composite Systems is comprised of three business units including Films & Fabrics, Tape Solutions and Thin Films. Our ambition is to provide innovative solutions that combine material science, processing technology and design to save energy, provide protection, improve comfort, and give peace-of-mind to our customers. Our unique performance is delivered by passionate people, empowered to collaborate closely with our customers and solve their toughest challenges.
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 Composites, and together, let's protect what matters most!
Mention légale
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.
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.
JOB SUMMARY AND PURPOSE
The Quality Engineer I will support the Quality Manager to ensure that the Quality Management System and quality standards of the company are implemented and maintained at the Akron facility in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations.
ESSENTIAL FUNCTIONS AND RELATED OBJECTIVES:
• 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:
o Change management and review of change controls
o Investigation and CAPA management, including robust root cause analysis
o Complaint management and performance of complaint investigations
o Internal audit program and performance of internal audits
o Training program; conduct training when needed
o Preparation of Management Review materials/metrics
o ISO certification and maintenance 60%
• Support the oversight of product realization and commercial manufacturing activities, such as product/specification development, process capability, facilities/utilities/equipment qualification and maintenance, and materials management. 30%
• Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product. 20%
• Customer support, including:
o Support customer audits
o Product stewardship requests
Ce poste est-il fait pour vous ?
Education:
Bachelor's Degree - Life Sciences or Engineering discipline - REQUIRED
Licenses and Certifications:
ASQ certifications (e.g. CQE, CQM, CQA) 3 Years - Preferred
Work Experience:
3+ years - 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
1 year - Quality role (Quality System development, implementation, and/or execution) within a manufacturing environment - REQUIRED
Employee is responsible to:
• Know and understand the quality and safety policies.
• Complete all quality and safety training required for the specific position.
• Follow all quality and safety rules and procedures and remind others through coaching and leading by example.
• Commit to addressing and reporting any unsafe condition or quality issue immediately.
• Be empowered and speak up when unsafe behaviors are observed or quality issues arise and to not place blame while investigating these issues.
• Adhere to the principles of data integrity.
On vous en dit plus sur nous
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
Pour être sûr de ne rien oublier
Saint-Gobain's innovations touch almost every major industry around the world, Composite Systems is comprised of three business units including Films & Fabrics, Tape Solutions and Thin Films. Our ambition is to provide innovative solutions that combine material science, processing technology and design to save energy, provide protection, improve comfort, and give peace-of-mind to our customers. Our unique performance is delivered by passionate people, empowered to collaborate closely with our customers and solve their toughest challenges.
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 Composites, and together, let's protect what matters most!
Mention légale
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.
Created: 2024-08-22
Reference: USA09842
Country: United States
State: Ohio
City: AKRON
ZIP: 44306
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