Quality Assurance Manager - Minneapolis, United States - Laborie Medical Technologies Corp

Description

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

At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success.

If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you.

We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good.

We're not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers.

We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We're Looking For:

As a key member of the Qualityteam, the Manager of Quality Assurance will be responsible for developing and establishing quality strategies, objectives, procedures and policies for the facility and organization.

They will provide leadership and delegate to facility QA personnel and will influence facility's senior management to encourage continuous improvement of quality and compliance.

The Manager of Quality Assurance will proactively identifies/resolves internal and external compliance risks using conceptual thinking as required and will be responsible for department budget.

About the Role:

Using participative and highly involved leadership style develops and directs quality strategies, objectives, procedures, and policies that support product manufacturing and distribution for long-term success of the business.

Provides team leadership, development and talent management activities including coaching, hiring, performance management, training, budgeting, and resource forecasting.

Leads and performs implementation of new processes that enhance the customer experience and engages all employees in a quality-focused mindset.

Leads internal audit program including scheduling, facilitating the audit, and driving required corrective actions.

Maintains knowledge of applicable quality regulations and standards including 21CFR820, ISO 13485:2016, MDR 2017/745, and CMDR SOR98/282.Implements policies, practices, procedures and standards by which all operations are performed including purchased material quality, internal/external audits, CAPA, complaint investigations, validations, SOPs, cleanroom operations, and sterilizations.

Minimum Qualifications:

Bachelor's degree with at least 8 years of quality experience, include 3 years of medical device experience and at least 1 year of team leadership experience.

Significant FDA and Notified Body inspections and audits experience.
Deep understanding and clear ability to interpret and apply medical device standards and ethical guidelines.

Ability to organize complex ideas in a clear, strategic manner with appropriate supporting details and ability to efficiently discuss the same with regulators, technical personnel, and management.

Excellent verbal communication and technical writing skills, strong problem-solving skills and attention to details, along with strong negotiating skills, ability to think creatively, analytically and develop creative solutions.

Preferred Qualifications:
ASQ and lean six sigma certificationsDrug-device combo experienceExperience scaling up Operations

Why Laborie:

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.

Paid time off and paid volunteer timeMedical, Dental, Vision and Flexible Spending AccountHealth Savings Account with Company Funded Contributions401k Retirement Plan with Company MatchParental Leave and Adoption ServicesHealth and Wellness Programs and EventsLaborie provides equal employment opportunities 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.

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