Primary Location USA Region-United States-Missouri-Columbia
Other Locations
Job Type Experienced
Description
3M Health Care - Delivering Value for the Advancement of Health Practices and Outcomes
For more than a century, people worldwide have looked to 3M for new products and ideas that solve everyday problems and make their lives easier and better. For decades, hospitals, clinics, dental offices and laboratories have trusted 3M as a dedicated partner supplying essential products designed to meet the unique needs of health professionals, thereby contributing to the advancement of better health practices, outcomes and quality of care.
We are looking for a Quality Manager for our drug manufacturing operation site located in Columbia , MO. The candidate will be responsible for the following:
Assuring compliance with all cGMP requirements.
Representing 3M and the Columbia site during FDA audits of facility.
Supervising both the quality engineering and quality control organizations.
Representing the quality function to external auditors as well as within business teams or on plant operating teams.
Meeting the business quality objectives and for communicating the results for this 3M business.
Expert/master knowledge and experience with the most current industry practices within quality assurance, product quality control, incoming quality control, Six Sigma, ISO, and cGMP
10% travel required
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status)
Qualifications
Basic Qualifications:
Bachelor's Degree in Science or Engineering
Minimum 7 years pharmaceutical/drug manufacturing experience
Minimum 1 year supervisory experience
Minimum 3 years of experience working within an FDA/GMP regulated quality role
Preferred Qualifications:
Prefer Master's Degree in Chemical Engineering or Mechanical Engineering Degree.
Significant experience in successfully leading teams and projects is required.
Knowledge of medical device regulations and demonstrated experience.
Knowledge of 3M systems.
Demonstrated proficiency in the use of statistical and quality engineering tools such as exploratory data analysis, basic statistics, Gage R&R, Analysis of Variance, Failure Modes and Effects Analysis, Statistical Process Control and Capability, acceptance sampling, correlation and regression, and experimental design.
A good working knowledge of more advanced statistical tools such as response surface designs, modeling, and optimization; and a general awareness of reliability engineering tools.
Excellent verbal and written communication skills is required.
Solid IT skills and familiarity with IT systems is required.
ASQ Certified Quality Engineer or Quality Manager.
Previous Six Sigma experience.
Demonstrated ability and experience in hosting FDA GMP audits.
Demonstrated ability to lead, develop and implement quality systems that support continuous and step product quality improvements.
Manufacturing and drug product development experience.
About 3M
3M captures the spark of new ideas and transforms them into thousands of ingenious products. Our culture of creative collaboration inspires a never-ending stream of powerful technologies that make life better. 3M is the innovation company that never stops inventing. With $27 billion in sales, 3M employs about 80,000 people worldwide and has operations in more than 65 countries. For more information, visit www.3M.com or follow @3MNews on Twitter.
DiversityInc - 11 months ago
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