Mgr QA - Risk Management Process

Medline•Northfield, MN

About The Position

Responsible for managing quality and compliance for applicable products and processes within assigned departments. The role adapts departmental plans and priorities to address resource and operational challenges, supports quality and regulatory compliance across product life cycles and regions of distribution, and works with internal and external stakeholders to resolve quality issues and maintain customer satisfaction. It also includes overseeing staff and day-to-day group operations, contributing to budgetary impact, and implementing departmental policies and procedures.

Requirements

Typically requires a bachelor's degree in Engineering, Science, or a technical field, or relevant experience.
At least 4 years of experience related to the design or operation of medical device or drug combination product platforms, design controls, and risk management, including work under QSR/GMP/ISO requirements or other regulated-industry requirements such as 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
Broad technical knowledge of relevant standards and regulations, including 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
Proficiency in analyzing and reporting data to identify issues, trends, or exceptions, drive improved results, and find solutions.
Demonstrated ability to control and coordinate concurrent projects, competing priorities, and critical deadlines.
Advanced Microsoft Excel skills, such as using AVERAGE, merging and centering cells, printing a centered page, and/or creating a pivot table.

Nice To Haves

At least 2 years of supervisory or managerial experience.
Experience in the medical device, pharmaceutical, food, cosmetic, or personal products industries.

Responsibilities

Ensure quality and regulatory compliance with applicable regulations, including QSR, GMP, and ISO requirements, across relevant product life cycles and regions of distribution.
Act as a liaison with divisions, suppliers, manufacturing, and operations to ensure product quality and customer satisfaction.
Manage complaints and develop approaches to solve problems identified during investigations.
Identify and manage continuous improvement projects.
Assist the division with product evaluations from quality assurance and regulatory compliance perspectives.
Assist with planning design, testing, inspection, and process validations to assure the quality of products or components.
Ensure quality issues are resolved in a timely manner to customer satisfaction.
Resolve product or production quality issues by interfacing with internal and external customers.
Oversee day-to-day operations of a group of employees and provide general guidelines and parameters for staff functioning.
Interpret and execute departmental or project policies; develop, recommend, and implement new or modified policies.
Hire staff; recommend pay increases; conduct performance reviews; train and develop staff; estimate personnel needs; assign work; meet completion dates; and ensure consistent application of organizational policies.
Coordinate concurrent projects, competing priorities, and critical deadlines.
Travel up to 25% of the time for business purposes, including within state, out of state, and/or internationally.

Benefits

Competitive total rewards package.
Continuing education and training.
Health insurance for eligible employees.
Life insurance for eligible employees.
Disability insurance for eligible employees.
401(k) contributions.
Paid time off.
Employee Assistance Program access for employees working less than 30 hours per week on average.
Employee Resource Groups for employees working less than 30 hours per week on average.
Employee Service Corp access for employees working less than 30 hours per week on average.
Bonus and/or incentive eligibility.