Quality Manufacturing Director — Regulatory Excellence

Medline Industries, LP; Norristown (Montgomery County); On-site; USD 134,000 - 201,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Bonus eligibility

Job summary

Medline Industries, LP seeks a driven Quality Assurance and Regulatory Compliance professional to oversee the quality and regulatory compliance for assigned product lines and processes. The role adapts departmental plans to meet resource and operational challenges while ensuring compliance across lifecycle stages.

You will coordinate with divisions, suppliers, manufacturing, and operations to ensure high-quality products, handle complaints, and drive continuous improvement initiatives.

Qualifications

• Education: Bachelor’s degree in Engineering, Science, or Technical Field, or equivalent experience.
• 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.
• Knowledge/Skills/Abilities: Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR) and proficiency in data analysis to drive improvements and manage concurrent projects.

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP, ISO) for product life cycle and distribution regions.
• Liaise with Divisions, Suppliers, Manufacturing, and Operations to ensure quality products and customer satisfaction.
• Manage complaints and develop new approaches to solve problems identified during investigations.
• Identify and manage execution of continuous improvement projects.
• Assist in product evaluation from a quality assurance and regulatory compliance standpoint.
• Assist in planning 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 with internal and external customers.

Skills

Regulatory compliance knowledge

Excel proficiency

Project management

Education

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

Job description

Medline Industries, LP seeks a driven Quality Assurance and Regulatory Compliance professional to oversee the quality and regulatory compliance for assigned product lines and processes. The role adapts departmental plans to meet resource and operational challenges while ensuring compliance across lifecycle stages.

You will coordinate with divisions, suppliers, manufacturing, and operations to ensure high-quality products, handle complaints, and drive continuous improvement initiatives.