Quality Engineer II

Saint-Gobain Performance Polymer Solutions; Clearwater (FL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Life insurance

Job summary

Saint-Gobain Life Sciences is seeking a Quality Engineer to support the implementation, maintenance, control and monitoring of quality systems across production. You will ensure compliance with corporate quality policies, regulatory requirements, ISO standards and customer specifications, reporting to the Quality Manager.

Responsibilities include supporting ISO internal audits, operator training, participating in customer and registrar audits, managing document control, CAPA events, and

Qualifications

• Bachelor's degree in Engineering or related field.
• ASQ CQE or CQA certifications preferred.
• 2+ years manufacturing experience in a regulated industry.
• Knowledge of ISO 9001, cGMP, and ISO 13485; preferred.

Responsibilities

• Support ISO internal audits and supplier audits.
• Train operators on quality processes and policies.
• Participate in customer and registrar audits and management reviews.
• Oversee document control, CAPA/SCAR processes, and risk-based decision making.
• Address customer requests promptly while maintaining professional communication.

Skills

Quality systems knowledge

ISO 9001

cGMP

ISO 13485

Auditing

Education

Bachelor's degree in Engineering

Tools

ASQ CQE

Six Sigma training

Job description

WHY DO WE NEED YOU?

The Quality Engineer is responsible for supporting the implementation, maintenance, control, and monitoring of quality systems and standards that ensure the quality of materials and products at every stage of production. This role ensures compliance with corporate quality policies, regulatory requirements, ISO standards, and customer specifications/expectations.

WHY DO WE NEED YOU?

The Quality Engineer is responsible for supporting the implementation, maintenance, control, and monitoring of quality systems and standards that ensure the quality of materials and products at every stage of production. This role ensures compliance with corporate quality policies, regulatory requirements, ISO standards, and customer specifications/expectations. Reporting to the Quality Manager, the Quality Engineer takes a hands‑on approach to support continuous improvement quality systems. These systems include receiving, in-process and final inspection, product auditing, certification, calibration, complaint handling, EVENT/CAPA/SCAR processes, nonconforming material control, product stewardship, and regulatory requests. The role will involve supporting ISO internal audits, training operators, participating in customer and registrar audits, management review, and overseeing document control. A key aspect of this role involves utilizing risk-based thinking and critical analysis to develop strategies for mitigating identified risks while maintaining business continuity. When uncertainty arises, consultation with management is required to determine the best course of action. The ability to assess strengths, weaknesses, and alternative solutions is essential for addressing challenges effectively. The Quality Engineer plays a crucial role in resolving customer requests and issues promptly while maintaining professional and tactful communication with both colleagues and customers. Regular, direct interaction with customers is required. Actively promotes a safe working environment, complies with proper use of PPE, reports incidents, and participates in functional department safety meetings.

IS THIS JOB FOR YOU?

This career position requires a Bachelor's degree - within Engineering field.

ASQ certifications (e.g. CQE, CQM, CQA) and training in Six Sigma/continuous improvement/WCM methodologies are preferred.

Professional Experience As Detailed Below Is Also Required

• 2+ years' manufacturing experience within regulated industry.
• Knowledge of and experience in quality systems, such as ISO 9001, cGMP, and ISO 13485; preferred.

a Little More About Us

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.

LEGAL STATEMENT

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.

Applicants for roles based in Washington state or remote roles that would be worked from Washington state are encouraged to direct any concerns regarding the state’s Pay Transparency laws to the SGNA HR Compliance team at [e-mail].

Benefits In Joining Us

At Saint-Gobain, our goal is to deliver a comprehensive Total Rewards package to support your well‑being and improve daily life for you and your family. We value your contribution to our purpose, Making the World a Better Home, and your Total Rewards package aims to help you plan for the future you want.

• 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

• Group Legal
• Identity Theft Protection
• Auto and Home Insurance
• Pet Insurance and Discounts
• Back-up Child & Elder Care
• PerkSpot Employee Discount Program