Saint-Gobain Senior Quality Engineer (clean room) in Beaverton, Michigan
Saint-Gobain in Beaverton, MI is seeking a Microbiologist to fill a senior-level Quality Engineer role. This Quality Engineer II will support the Quality Manager in ensuring the Quality Management System and quality standards of the company are implemented and maintained at the SGPPL facility in accordance with the corporate quality policies, applicable regulatory requirements, and customer specifications/expectations. The Quality Engineer II will serve as a delegate to the Quality Manager. This position will be responsible for all aspects of the Cleanroom Controls, including Environmental Monitoring, Dose Audits and Simulated Product Monster (SPM) Program. This position will also lead complaint investigations, nonconformance investigations, Supplier Corrective Action investigations, CAPA investigations, and drive continuous improvement projects throughout the plant. Position will be the lead or support for Engineering Changes, Gage R&R, or validations required to support existing/new processes.
The main responsibility of the Senior Quality Engineer is to ensure strict adherence and a commitment to corporate and/or local policies, rules, and regulations through the establishment and maintenance of an effective Quality Management System. An employee in this position must focus on customers' expectations (both internal and external) and strive for continuous improvement. Additionally, the Quality Engineer will oversee the work of the Quality Specialists.
Bachelor's Degree - Life Sciences or Engineering required
Minimum five (5) years of experience in a regulated industry, such as life sciences, food and beverage, automotive or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharma, or medical device).
Minimum three (3) years in a Microbiology or Quality role (Quality System development, implementation, and/or execution) within a manufacturing environment.
Experience with ISO Class 7 Clean Rooms required
Strong knowledge of ISO 13485, ISO 14644 and GMP requirements and relevant industry standard practices required.
Must have ability to interpret these regulations to ensure proper implementation in the plant systems.
Demonstrated understanding of Lean Manufacturing concepts desirable.
Must work well in a team environment, possess an ability to adapt to change in the environment, and have proven ability to exert influence in a directive and positive manner.
Proficient computer skills required including Microsoft Word, Excel, Visio, PPT, and Project.
Support and 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:
Cleanroom controls, including Dose Audits and SPM Program
Document control and review/approval of controlled documents
Change management and review of change controls
Investigation and CAPA management, including robust root cause analysis
Complaint management and performance of complaint investigations
Supplier quality management and performance of supplier audits as appropriate
Internal audit program and performance of internal audits
Training program; conduct training when needed
Implementation of Quality Risk Management in relevant aspects of the QMS Management Review
ISO certification and maintenance
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.