We believe that great healthcare is an essential safeguard of human dignity.

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

If you share our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion, and are looking to contribute and grow in a fast-paced environment, join us to enhance our customer experience with dignity, at the heart of everything.

Laborie Medical Technologies is currently searching for a Manager Quality Assurance to join our team in the Salt Lake City, Utah office.

Position Overview:

This individual will develop and establish quality strategies, objectives, procedures, and policies for the facilities and organization. They will provide leadership and delegate to facility QA personnel. Also, influence facility’s senior management to encourage continuous improvement of quality and compliance. The Manager Quality Assurance will proactively identifies/resolves internal and external compliance risks using conceptual thinking as required. Furthermore, they will also be responsible for department budget.

How you contribute:

• Using a participative and highly involved leadership style develops and directs quality strategies, objectives, procedures, and policies that support product manufacturing and distribution for the long-term success of the business.
• Provides team leadership, development, and talent management activities including coaching, hiring, performance management, training, and budgeting, resource forecasting,
• Influences facility’s senior management on sensitive and complex matters.
• Leads implementation of new processes that enhances the customer experience and engages all employees in a quality-focused mindset.
• Directs staff to encourage continuous improvement of quality and compliance across programs and functions.
• Participates in talent management activities including human resource forecasting, hiring, cross-function interviewing,
• Plans, coordinates and directs quality programs and activities delivering sustainable processes that produce high-quality products.
• Leads the internal audit program including scheduling, facilitating the audit and driving required corrective actions.
• Implements policies, practices, procedures, and standards by which all operations are performed including purchased material quality, internal/external audits, CAPA, complaint investigation, validations, SOP’s, cleanroom operations, and sterilization
• Proactively identifies/resolves internal and external compliance risks that may include moderately complex trade-off decisions.
• Maintains knowledge of applicable quality regulations and standards including 21CFR§820, ISO 13485:2016, MDR 2017/745, and CMDR SOR98/282.
• Translates quality regulations and standards into practical and compliant processes and procedures.
• Performs document reviews for quality impacts.
• Drives manufacturing process validations
• Acts as key escort in external audits and inspections.
• Assist in quality due diligence for potential acquisitions.
• Owns and drives assigned quality projects.
• Responsible for resource forecasting and budgeting
• Execute miscellaneous tasks, as assigned.

Qualifications:

• Bachelor's degree.
• At least 10 years of quality experience that includes at least 3 years of medical device experience.
• At least 3 years of team leadership experience emphasizing teamwork, quality and collaboration.
• Significant FDA & Notified Body inspections / audits experience
• Excellent verbal communication and technical writing skills. Must be able to organize complex ideas in a clear, strategic manner with appropriate supporting detail. Able to efficiently discuss the same with regulators, technical personnel, and management.
• A deep understanding and a clear ability to interpret and apply medical device standards.
• Knowledge and understanding of ethical guidelines of the profession.
• Must have very good problem-solving skills and attention to details. Strong negotiating skills; able to think creatively, analytically and develop creative solutions.
• Ability to independently solve problems, lead projects, and influence teams
• Crisp decision-making, following appropriate consultation.
• Demonstrated ability to work as a team player with multi-disciplinary project teams.
• Proficiency in MS Word and Excel.
• ASQ and lean six sigma certifications preferred.

How we take care of you:

• Paid time off and Volunteer time
• Paid holidays
• Flexible work schedule and environment
• Medical, Dental, Vision, and Employee Wellbeing programs
• Health Savings Account and Flexible Spending Account
• Parental Leave and Adoption Services
• 401k Retirement Plan with Company Match
• Company-paid short-term and long-term disability and Basic Life and AD&D

Laborie is a specialty manufacturer and supplier of medical technologies and devices, committed to excellence in diagnostics and therapeutics for Urological, Gastrointestinal, Obstetric, Gynecological, and Neonatal healthcare and committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education and employment for individuals with disabilities.

www.laborie.com