Saint-Gobain Quality Specialist in Gaithersburg, Maryland
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.
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 Specialist will be responsible for supporting the quality systems by maintaining quality systems records, tracking processes, and verifying documentation for compliance with quality standards for the Gaithersburg site, which manufactures custom products used in cell and gene therapy clinical trials, critical applications in final fill assemblies, and molded components in ISO 7 and ISO 8 cleanrooms.
Administers and maintains control of quality, document control, and training systems and processes which monitor, assess, and approve the quality of materials and products at all stages of production to include electronic Quality Management System (eQMS). Performs periodic reviews to verify compliance to procedures.
Track Corrective Action Preventive Actions (CAPA), Nonconformance (NMR), and Supplier Corrective Action Requests (SCAR) and work with cross-functional areas to ensure compliance and on time closures.
Perform investigations and execute CAPAs to support site objectives and continuous improvement efforts as required.
Support the implementation of continuous quality improvement objectives, primarily ISO 13485: 2016 through change control, CAPA and projects.
Coordinate the document control process ensuring that documents are released and records are properly closed. Revising documents as needed to support the site.
Coordinate the change control process ensuring changes are being closed in a timely manner. Provide awareness to aging change controls and initiate changes as needed.
Coordinate the customer complaint handling process, ensure customer notifications are issued per procedure and that complaints are managed through to closure.
Support customer and third part audits through preparing of documentation and audit readiness for the site.
Support supplier quality by completing supplier questionnaires, maintaining vendor files, conducting supplier audits, and fulfilling customer requests and product inquires.
Perform Receiving, In-process, Final Inspection/Testing, Batch Record Review as required.
Support product validation and design verification activities.
Assist with the execution of management review and follow up of actions.
Other duties as assigned.
High School Diploma or equivalent is required. Bachelors degree is preferred.
Requires 3 - 5 years of relevant work experience in a regulated industry.
Knowledge of and experience in quality systems (21 CFR 820, ISO 13485:2016) required.
Experience with MRP/ERP system (QAD, SAP, Oracle, Fourth Shift, etc.) preferred.
Experience with eQMS system (ETQ, Master Control, MQ1, etc.) required.
Strong organizational and communication skills, both written and verbal.
Strong technical writing and investigative root cause analysis skills.
Must have the ability to multitask.
The completion of an audit course or training is preferred.
raining in six sigma / continuous improvement methodologies is a plus.
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.