Posted in Other 30+ days ago.
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Type: Full Time
Location: Hercules, California
QUALITY ENGINEERING MANAGER (QUALITY MANAGER II)
# of Openings
Quality & Regulatory
Are you an experienced Quality Engineering Manager looking to take the next step in your career* Do you have a passion for process improvement and sustainability of Quality Management Systems* Are you looking to lead a tight-knit team of quality engineering professionals in a stable and secure environment* Then we have the role for you! Bio-Rad Laboratories is currently looking for a Quality Engineering Manager for the Hercules, CA location.
* You will be responsible for a team of Quality Engineers, and Quality System Specialists supporting various Clinical Diagnostic Group Northern California (CDG NorCal) Quality Management System (QMS) programs, including design control, CAPA, complaint investigations, change control, post market surveillance and root cause investigations for multiple business division product lines manufactured and distributed out of the CDG NorCal QMS.
* You will also oversee creating, updating and managing product and process risk files, including leading or participating in cross functional teams during design control, change management, new product introduction and CAPA activities.
* You will also be leading the development and sustainability processes for the management of risk (ISO 14971), usability (ISO 62366) activities during various design control phases through post market surveillance, and complaint investigations, including, but not limited to:
* Creation of internal procedures, development and deployment of training material related to these activities.
* Overseeing the creation and maintenance of Internal Supplier MOUs and supporting external supplier agreements as needed.
* Responsibility for overseeing the review and approval of validation activities in support of manufacturing operations and global logistics.
* Additional responsibilities include training key stakeholders on various QMS processes (e.g. risk management, CAPA, complaint and nonconformance investigations, etc.) and the development and maintenance of Quality Analytics related to the overall performance of the Quality Management System, with an emphasis on post market product performance.
* Bachelor s degree or equivalent in an engineering/science/technical field or related discipline.
* 8+ years of job related experience with supervisory experience and an emphasis on working in a cGMP/QSR/ISO regulated industry.
* Preferred candidates should have experience working under FDA regulations and ISO standards.
* Experience supervising/managing a quality systems program in a regulated environment a plus.
* Experience with the development, manufacture or support for in vitro diagnostics or biological product testing highly desirable.
* Experience with managing product and process risk files a plus.
* Lead ISO auditor certification desirable.
* Certified Quality Engineer, Quality Manager, Six Sigma Green or Black Belt desirable.
* Excellent written, verbal and presentation skills, including the ability to persuade others with fact-based arguments.
* Skilled in statistical methods, statistical process control and sampling plans.
* Good organizational skills, including the ability to manage multiple projects simultaneously, with follow-through and ability to meet defined deadlines.
* Strong interpersonal skills are necessary to operate in a team environment to interact with multiple departments under a variety of conditions.
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.