Reference : 584767
Quality Process Control Engineer
- Technical Production
- United States , Clearwater , CLEARWATER
- Posting date : 01/25/2021
- Technical Production
- United States CLEARWATER
- Permanent / Regular (US)
- Posting date : 01/25/2021
The QPC Engineer will ensure that the quality standards of the company are maintained within the plant procedures, policies, purchased components and manufactured products. They will participate in and will lead internal nonconforming event investigations. they may also lead or participate in complaint investigations, CAPA investigations, supplier audits, supplier quality, conduct internal audits and drive continuous improvement projects throughout the plant.
They may support any facility expansions, software validations, equipment qualifications and / or process validations required to support existing / new processes. The QPC Engineer will participate in third party audits and conduct training to plant personnel when needed. The QPC Engineer will help perform the implementation, maintenance and control of systems & practices, which monitor, assess, and approve the quality of materials and products at all stages of production. Responsible for implementing, maintaining, and facilitating continuous quality improvement objectives, primarily cGMP and ISO 13485 for the plant. May serve as the delegate for the Quality Manager.
- Lead to resolution of internal and external quality issues such as inquiries, quality events, SCARs, complaints, nonconformance’s, CAPAs, audits utilizing sound problem solving methodologies
- Oversight of cleanroom and production practices including qualification, monitoring and behavior
- Conducts training, coordinates functions, resolves issues/problems, and manages projects requiring direction of others throughout the facility as needed.
- Able to operate independently and as part of a team to meet customer requirements.
- Validation activities
- Management of Equipment Calibration for measuring, inspection and process equipment
- Implementation/oversight of QA testing and QA product release
- Project Management
- Participate and lead continuous improvement activities.
- Supplier Quality
- Bachelor’s degree in Engineering or Science/ Relevant field or equivalent experience required
- 3-5 years’ Manufacturing Environment (ISO or GMP Environment) required
- Strong background and experience in quality systems (Ex: 21 CFR Part 820, ISO 13485) and quality tools (SPC, Statistical Analysis, etc.) required
- Strong technical writing and investigative skills required
- Proficient with Microsoft Access, Excel and Word required
- Experience with ISO 13485, 21 CFR 820 preferred
- Continuous Improvement (WCM, Kaizen) green belt training or higher preferred
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.
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.
Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, 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.