Dir Manufacturing Quality

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.

Requirements

• Education: Minimum – Bachelor’s degree in Engineering, Science, or Technical Field. Preferred – None.
• Certification / Licensure: None.
• Work Experience: Minimum – 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. Preferred – 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.
• Knowledge / Skills / Abilities: Minimum – 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 – None.

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