Dir, QA (Product Quality)

Job Summary

Responsible for providing leadership and direction to Quality team(s) to ensure quality and compliance for the applicable products and processes for assigned department(s). Develop strategy, translate into functional plans and guide execution of long-term goals.

Major Responsibilities

• Direct the development of product specifications for Medline branded products; such as the testing requirements, procedures and methods for testing, inspecting or qualifying new products and suppliers.
• Partner with Supplier Audit department and Division to determine optimal Supplier relationship.
• Develop and implement strategy for the Quality department(s) based upon Quarterly Management Review.
• Prepare and deliver Customer presentations.
• Act as liaison with Senior Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on time delivery, and customer satisfaction.
• Collaborate with Suppliers, manufacturing partners and product managers in developing and implementing QA programs.
• Oversee QSR for assigned department(s) and ensure compliance as measured by FDA/ISO/internal audits.
• Management responsibilities include: Typically, manages through multiple Managers. Provides leadership and management to one or more major departments of an operating unit or to a department that has system-wide accountability.
• Strategic, tactical and operational planning (12 + months) for the function or department.
• Direct budgetary responsibility for one or more departments, functions or major projects/programs.
• Interpret and execute policies for departments/projects and develops.
• Recommend and implement new policies or modifications to existing policies.
• 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.

Minimum Job Requirements

Education: Typically requires a Bachelor's degree in Engineering, Science, or Technical Field.

Certification / Licensure: None

Work Experience: At least 7 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). At least 4 years of management experience.

Knowledge / Skills / Abilities: Depth of 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 a pivot table). Position requires travel up to 30% of the time for business purposes (within state, out of state and/or internationally).

Preferred Job Requirements

Work Experience: At least 6 years of managerial experience preferred. At least 8 years of related experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products industries preferred.