Quality Senior Manager

Job Responsibilities

• Develop and implement strategies to facilitate the progress of Sanmina's worldwide medical division.

• Work with assigned Medical Division facilities on conformance to company quality and regulatory initiatives.

• Serve as liaison with the FDA and other regulatory agencies as assigned Interface with plant management teams, customers and notified bodies as assigned

• Review technical reports and summary documents for adherence to regulatory guidelines, strategies, and commitments.

• Recommend regulatory policies to assure adherence to FDA requirements.

• Contribute to the modification, development and implementation of company practices and policies for quality and regulatory affairs.

• Assist in the scheduling and tracking of project and operational activities for the Medical Division.

• Keep abreast of all pertinent laws, regulations and guidance and provide insight on current regulations and guidance documents relevant to product development projects.

• Provide input on regional regulatory strategies and implementation activities.

• Prepare Standard Operating Procedures and provide review of SOPs as necessary.

Job Requirements:

• Bachelor's Degree in a scientific discipline.

• At least 7 years experience in a Quality/Regulatory and manufacturing environment.

• Experience with Device submissions is a plus. (510K, PMA, IDE).

• Expert knowledge of FDA regulations.

• Strong written and verbal communication skills necessary.

• Proficient use of technology including MS Office Software Package and Internet resources is expected.

• Must demonstrate professionalism in all working environments.

• Must be able/willing to travel globally.