Manager Quality Assurance, Audit Sterilization/Micro

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:
• At least 2 years of supervisory/managerial experience.
• Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.
• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• The anticipated salary range for this position:
• $116,000.00 - $174,000.00 Annual
• The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
• We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here .

Benefits

Additional Information

Job Summary This role needs to be based in commuting distance to our corporate headquarters in Northfield, IL. Relocation assistance may be available for the right candidate. 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

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