Sr. Design Quality Engineer - Manufacturing, Life Sciences; Remote, USA

If you want to 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 Sr. Design Quality Engineer is responsible for supporting quality engineering activities to support the new product development life cycle, from concept to commercialization.

Will serve as the key quality resource on the cross functional new product development teams for ensuring compliance to ISO 9001, ISO 13485, Saint-Gobain global quality management procedures, and relevant regulatory and industry standards.

Leads the execution of quality owned design activities following the ISO 9001, and ISO 13485 Quality Management system standards and applicable regulations.

Key Functions:

New Product Development:

Supports and assures the quality oversight for the new product introduction for single use assemblies in compliance with corporate quality policies, procedures, ISO 9001/13485 standards, relevant regulatory requirements, and industry guidance, including:

• Provides direction & support for design control activities per ISO 13485 for new product introduction.
• Executes the quality owned deliverables as identified as part of the Design processes.
• Reviews, assesses and provides quality approval for the New Product Development documentation to ensure compliance throughout product development cycle.
• ensures the product design meets customer expectations, ISO standards, regulatory requirements, and corporate requirements. Shows focus toward continuous improvement.
• Contributes to the risk management for new products and provides assurances that control measures are translated into appropriate (critical) requirements (Design outputs).
• Troubleshoots & directs the resolution of quality issues by fostering effective cross-functional partnerships.
• Investigates & liaises with operation & design teams on design related product complaints to resolve difficult quality problems on products.
• Directs and facilitates investigations and the corresponding preventive and corrective actions that result from quality inquiries, abnormal results or other quality performance indicators for new products.
• Analyzes development and product data for trends related to product safety, quality and performance.
• Trains, coaches and increases awareness while promoting a culture focused on patient safety and quality.

Supplier Qualification:

• Supports qualification of new suppliers being introduced through the new product introduction process following the requirements of ISO 9001 and ISO 13485, relevant industry standards, regulations, and corporate requirements.
• Participates and provides input to purchasing control processes, procedures, and systems in compliance with applicable regulations for new supplier or new components being introduced.
• Verifies the regulatory and product compliance of the new supplier and/or new components in accordance with defined new product requirements.
• Liaises with purchasing team to support supplier related duties and responsibilities.
• Supports remediation of regulatory and product compliance for existing suppliers and components as part of corporate initiatives

Bachelor's Degree within Biology, Microbiology, or other relevant scientific/engineering field; Required.

5+ years of experience - within Quality, within a regulated industry with a preferred emphasis in life sciences (i.e. pharma, biopharma or medical device).

2+ years of experience - with Design/Controls experience; Required.

Strong knowledge of ISO and cGMP requirements and relevant industry standard practices; Required.

Knowledge of Quality Management Systems and Product/Process Life Cycle Management within manufacturing; Required.

Capable of measuring product characteristics & reading/interpreting technical instructions, drawings & blueprints; Required.

Ability to Travel upwards of 15%; Required.

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.

Join Us at Saint-Gobain Life Sciences. Together, we'll create a better life.

Click here to Explore more opportunities within Saint-Gobain Life Sciences..

Certain states require pay information be provided in job postings. Saint-Gobain aims to deliver a comprehensive Total Rewards package to support our employees'wellbeing and help improve daily life for themselves and their families. We believe in the importance of pay transparency in what we offer prospective candidates and provide the national pay range for this position which is $87,500 to 135,500 per year, however, the base pay offered may vary depending on geographic region, internal equity, job-related knowledge, skills, and experience among other factors.

In addition to base salary, this position is eligible for an annual bonus. The targeted bonus amount is 12% of base salary based on company and individual performance measures. The Total Target Cash range (base pay and annual bonus) for this position, is $98,000 to $151,760. Bonus payments are part of variable compensation and by nature can vary based on company and individual performance and is not a guarantee.

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.

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  • 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.

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    • 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

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  • 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 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.