QA and Supplier Specialist (#0076) Singulex

Summary

Description

Develop and implement QA supplier qualification and approval process.
Develop and maintain QA supplier files and documentation.
Assist in the audit of Contract Manufacturers and sole source suppliers.
Develop supplier performance metrics.
Compile, analyze, trend and issue QA performance metrics reports.
Support the development and implementation of a Quality Management System to comply with ISO and FDA GXP standards and regulations.
Perform Incoming Quality Assurance inspection of raw materials and components.
Coordinate the CAPA and Non-Conformance Report resolution process to completion and maintain files.
Write standard operating procedures and work instructions for QA actions. Perform other duties as assigned.

Qualifications

College, technical courses, 2+ year degree preferred.
5+ years related QA and supplier qualification experience or equivalent education and work experience.
Medical device, electronic instrumentation, In-vitro diagnostic and CLIA/GLP laboratory experience preferred.
Strong understanding of QSR, ISO and GLP regulatory requirements is required.
Able to work independently, without instruction.
Demonstrated proficiency with Excel, PowerPoint, and Word programs is essential.
Must have excellent written and verbal communication skills and the ability to understand, prepare, and communicate technical information to a wide range of audiences.
Excellent cross-functional team leadership and participation skills.
Highly organized and detail-oriented.
Results and goals oriented.
Excellent written and oral communication skills.
Ability to work in a fast paced and changing environment.
Good people skills. Ability to supervise team members with a positive attitude, control negativity and promote team work at all times.
Effective personal communication skills.
Flexible and quickly adaptable to changing priorities.
Having integrity and a strong work ethic.
Passionate for both personal and corporate success.
Ability to work independently with minimal supervision and as a member of a team.
Commitment to quality.
Enthusiasm, attention to detail, the ability to meet aggressive deadlines, ability to think out of the box, and ability to work effectively with others in a fast paced, highly-productive environment.

Location:	3507 Breakwater Ave Hayward, CA 94545 United States