Manager, Quality Assurance

United States of America, Arizona, Tucson

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Impact Healthcare

At Roche Tissue Diagnostics, our mission is to improve the lives of all patients afflicted with cancer. As an innovator of tissue-based diagnostic solutions for patients worldwide, we provide the anatomic pathology lab with a powerful combination of instrumentation, medical value assays and digitally integrated workflow. Strengthening diagnosis improves chances of survival for the millions of people living with cancer, which means precise, personalized diagnostics are critical as we continue the fight against this deadly disease.

Make a Big Difference

As a Manager of Quality Assurance, you will develop, implement and maintain quality control systems and activities with oversight for product quality, effective quality systems and conformance to regulations our Tucson-based operations. Develop inter-connectivity between Diagnostic functions, Pharma Services, Critical Reagents and Final Quality assurance staff. Handle cost center, staff development, quality system compliance, regulatory compliance, policy deployment and AIP management for continuous improvement activities.

Responsibilities:

  • Ensure products consistently and optimally meet specifications.

  • Monitor production processes to ensure quality specifications are met.

  • Own the development and implementation of Quality System in instrument and reagent manufacturing, Pharma Services and Critical Reagent labs.

  • Ensure compliance with applicable regulations and standards, including: FDA QSR and ISO-13485, Canadian and applicable geographical requirements including, but not limited to, Japan.

  • Lead root cause analysis, countermeasures and corrective actions for complaint review and in-house non-conformance.

  • Review and approve design and document changes.

  • Manage quality inspection services.

  • Have ownership for budgets, staffing resourcing needs, and performance reviews.

  • Collaborate with and bring up issues to Manufacturing and Regulatory Affairs.

  • Champion GMP/GLP and quality practices.

  • Perform duties as the need arises as a Management Representative alternate.

  • Sharpen our quality focus by being a champion of Quality policy to strengthen our foundation for future growth.

  • Promote the application of MDI principles including: QCDS measurements, visual management, standard work, team development.

  • Lead staff through coaching/mentoring, training and crafting opportunities to develop skills, while providing ongoing, constructive and timely feedback on performance and progress toward goals and expectations.

  • Other duties as assigned by management.

Who You Are

When you join us, you will have a meaningful career while working with an innovative technology that saves and improves lives around the world. As you collaborate with some of the best in the industry, you will make a huge difference in disease diagnostics! Our team is collaborative and fast-paced. And, we offer a competitive salary with a rich benefits package.

Requirements:

  • Bachelor’s degree in an applicable technical field; advanced degree is preferred. Or, equivalent combination of education and experience to perform at this level.

  • A minimum of 5 years of related experience including leadership experience along with a proven ability to develop and implement quality systems in the medical device industry.

  • 1-2 years of managerial/supervisory experience is preferred.

  • High level of experience aligning with FDA 21 CFR – Parts 820, Quality System Regulation.

  • Experience with lean manufacturing and/or Six-sigma tools is highly preferred.

  • A process advocate with strong attention to details.

  • Results focused with excellent facilitation/change agent expertise.

  • Strong leadership and team development skills.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.