Quality Senior Manager

SANMINA-SCI SYSTEMS SINGAPORE PTE. LTD.; Singapore; On-site; SGD 80,000 - 110,000; Full time

Job summary

A global technology company in Singapore is seeking an experienced professional to develop and implement strategies for their medical division. The ideal candidate will have at least 7 years in Quality/Regulatory environments, expert knowledge of FDA regulations, and exceptional communication skills. Responsibilities include liaising with regulatory agencies, reviewing technical reports, and ensuring compliance with quality initiatives. A Bachelor's Degree in a scientific discipline is required, and the candidate must be willing to travel globally.

Qualifications

• Minimum 7 years of experience in a Quality/Regulatory and manufacturing environment.
• Experience with device submissions (510K, PMA, IDE) is a plus.
• Demonstrated professionalism in all working environments.

Responsibilities

• Develop and implement strategies for the medical division.
• Work with facilities on compliance with quality and regulatory initiatives.
• Liaise with FDA and regulatory agencies.
• Review technical reports for regulatory adherence.
• Recommend regulatory policies for FDA compliance.
• Modify and implement quality and regulatory practices.
• Schedule and track project activities for the division.
• Stay updated on laws and regulations relevant to projects.
• Provide input on regulatory strategies.
• Prepare and review Standard Operating Procedures.

Skills

Expert knowledge of FDA regulations

Strong written and verbal communication skills

Proficient use of MS Office Software Package

Ability to travel globally

Education

Bachelor's Degree in a scientific discipline

Job description

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.