Phillips Plastics is a custom injection molder of both plastic and metal with annual sales nearing $260 million. Phillips Plastics Corporation has been setting the standard for injection molding services since 1964. State-of-the-art technology, an experienced staff, and collaborative partnerships result in unsurpassed quality and cost-saving manufacturing opportunities.

The primary focus of this position will be to provide support to the Strategic Medical Plan.

Objective
Expand the company’s core competencies in the Medical Device and GMP drug product manufacturing markets. Devise and implement quality systems/procedures that provide continuous improvement methodology supporting manufacturing, support groups and ensure customer satisfaction is maintained. Provide leadership and direction for the RA/QA activities for the medical business of Phillips Plastics Corporation. Function as a global resource in support of the medical device manufacturing, GMP drug packaging and medical component manufacturing products.

Key Responsibilities of the Position
• Ensure compliance with FDA/GMP and ISO quality system requirements.
• Work with Sales and Marketing to represent Phillips Plastics Quality System with customers and potential customers.
• Develop quality system to support the Strategic Medical Plan
• Perform other job-related duties, as well as those assigned at each criterion level to meet the objectives of the Strategic Medical Plan.
• Effectively use material, equipment and personnel in producing quality products
• Creation and recommendation of manufacturing policies, procedures and programs (such as process risk analyses, change control, corrective and preventive actions, batch trending, product complaints investigations)
• GMP training of personnel in collaboration with Quality and Regulatory functions
• Develop and implement internal audit teams with specific skills and emphasis on FDA/GMP requirements.
• Work with management on risk assessment and regulatory management.
• Interpret and enforce related SOP’s and cGMP regulatory guidelines.
• Develop and maintain and integrated quality system for medical products.
• Develop and implement internal audit teams with specific skills and emphasis on FDA/GMP requirements.
• Drive continuous improvement activities with emphasis on root cause analysis.

Requirements
Education / Experience
• Four year degree in a science (microbiology, chemistry, biochemistry) or engineering field; or equivalent mix of experience and education
• Minimum of 8 years of medical device and cGMP pharma manufacturing experience

Skills / Competencies
• Has lead and/or participated in cross-functional teams responsible for commercial launch of pharmaceutical products
• Intimate knowledge of 21 CFR 210 and 211, FDA guidance and familiarity with European guidance and regulations
• Intimate knowledge with the medical device Quality System Requirements 21 CFR 820
• Direct experience with audits and pre-approval inspections by regulatory authorities
• Strong interpersonal, verbal, and written communication skills
• Strong organizational skills

http://www.phillipsplastics.com/careers/employment_opps/235-1.html