Quality Manager (Regulated Industry)

About the Position

Quality Manager (Regulated Industry)

San Diego, CA

Full Time

Experienced

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About the Company

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

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Responsibilities

• Ensures the creation, revision, and enforcement of all aspects of MENTOR and the assigned client facilities Quality Management System (QMS).
• Lead the events & root cause analysis processes.
• Oversight of the training programs and lead the inspection readiness programs, and vendor management programs.
• Lead the review and administration of quality service level agreement (SLA) and Quality Management Systems as it pertains to quality and compliance requirements.
• Responsible for the development and implementation of a strategy to ensure the client requirements are met.
• Will travel to support MTG clients and operations as required.

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Requirements

• Bachelor's degree in Sciences or Engineering is preferred.
• Minimum of five (5) years professional experience in compliance, quality systems and/or internal auditing within the regulated industry.
• Previous experience leading teams or projects.
• Requires strong technical writing skills (English and Spanish).
• Ability to effectively read, write and verbally communicate in English and Spanish.
• Computer literacy with MS Office applications (Word, Excel, Power Point, Outlook) and Quality Management Systems (e.g. Trackwise).
• Above average organizing, analyzing and a minimum of math (practical application of fractions, percentages, ratios, proportions, basic algebra) to determine organizational, Customer and regulatory problems and formulate corrective action plans.
• Ability to adapt to changing responsibilities.
• Requires effective interpersonal skills as demonstrated through prior experience.
• Ability to work independently under minimal guidelines and supervision.
• Working knowledge of applicable regulations and standards, including, but not limited to, GMP, GDP regulations and ISO standards.
• Ability to motivate, train and develop staff within the MENTOR’s team.
• Willingness to demonstrate through daily activities a model of continuous monitoring of quality system activities to ensure compliance with documented standards.
• Demonstrated ability to analyze data and performance metrics.
• Demonstrate decision making capabilities.

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Nice to Have

• Experience with quality compliance processes.
• Experience with quality system harmonization.
• Experience acting as a point of contact for customers, suppliers, and internal employees regarding all contracts and compliance requests.

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We Offer

• Competitive salary
• Opportunity to work with a leading company in the life sciences industry
• Professional growth and development opportunities

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Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.