Quality Assurance Manager

Job Summary

Responsible for managing the quality and compliance for applicable products and processes for assigned department(s). Adapt departmental plans and priorities to address resource and operational challenges.

Job Description

Responsibilities:

• Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product.

• Acts as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.

• Manage complaints and develop new approaches to solve problems identified during the investigation process.

• Identify and manage the execution of continuous improvement projects. Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint.

• Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components.

• Ensure all quality issues are resolved to customer satisfaction, in a timely manner. Resolve issues relating to product or production quality by interfacing with internal and external customers.

Management responsibilities include:

• Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments

• Day-to-day operations of a group of employees;

• May have limited budgetary responsibility and usually contributes to budgetary impact;

• Interpret and execute policies for departments/projects and develops.

• Recommend and implement new policies or modifications to existing policies.

• Provide general guidelines and parameters for staff functioning.

• Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

Requirements:

Education

• Bachelor’s degree in Engineering, Science, or Technical Field.

Work Experience

• At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).

Knowledge / Skills / Abilities

• Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)

• Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.

• Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.

• Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating apivot table).

• Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).

Preferred Requirements:

Work Experience

• At least 2 years of supervisory/managerial experience.

• Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.

Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.

Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.