Manager QA

About the role

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.

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations (e.g., QSR, GMP, ISO) pertaining to the product life cycle and regions of distribution.
• Act as a liaison with 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 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

• Typically oversees professional employees/teams or 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 develop or recommend 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, and interpreting and ensuring consistent application of organizational policies.

Requirements

• Bachelor’s degree in Engineering, Science, or Technical Field.
• 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 (21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).

Skills

• Broad technical knowledge of relevant standards and regulations (21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).
• Proficiency in analyzing and reporting data to identify issues, trends, or exceptions to drive improvement and find solutions.
• Demonstrated ability to control and coordinate concurrent projects, competing priorities, and critical deadlines.
• Advanced skill in Microsoft Excel (e.g., using AVERAGE function, merging and centering cells, printing centered pages, and/or creating pivot tables).
• Position requires travel up to 25% of the time for business purposes (within state, out of state, and/or internationally).

Preferred Qualifications

• At least 2 years of supervisory/managerial experience.
• Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.

Pay

The anticipated salary range for this position is $116,000.00 - $174,000.00 annually. The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible.

Benefits

• Health insurance, life and disability coverage.
• 401(k) contributions.
• Paid time off.
• Additional benefits for employees working 30 or more hours per week, including access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp.