QUALITY ASSURANCE MANAGER WITH PHARMACEUTICAL MENLO PARK, CA This is an ONSITE POSITION - Candidates must be local to Menlo Park, CA and willing to work onsite.
Project Description:
The Quality Assurance Manager will help establish the direction for the development, should execute and perform administration of quality system.
The Quality Assurance Manager will support cross-functional activities to assure compliance with quality system requirements.
Work closely with Quality Assurance Sr. Manager or Associate Director of Quality, direct or coordinate quality assurance. programs, formulate quality control policies, and support regulatory affairs activity related to FDA and international filings.
Coordinate the creation, review, and revision of Standard Operating Procedures to assure compliance with required regulations.
Coordinate and participate in audits by US FDA, State of California FDB, European notified bodies, and other international regulatory agencies.
Schedule, coordinate, and participate in Internal Audits of the Alydia Quality System.
Manage the CAPA and Complaints systems.
Manage the document control system.
Manage training programs for the quality system.
Develop and define quality metrics, analyze quality-related data, and participate in periodic management review of the quality system.
Support design control activities.
Provide input to the engineering team on aspects of quality engineering (e.g., statistical methods, test method development, metrology).
Maintain and revise Quality Agreements with contract manufacturer and suppliers.
Primary contact with contract manufacturer quality assurance department.
Audit contract manufacturer and suppliers for conformance with requirements.
Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, participating in professional societies.
Required Skills:
BS/BA or equivalent preferred.
Previous experience in Quality Assurance management preferably in the medical device field.
5+ years' experience with FDA QMS regulations, ISO 13485, FDA submissions, international standards.
5+ years of progressive experience in a medical device quality assurance role, as well as working in a cross-functional environment.
Experience participating in the development of quality systems for small companies.
Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel within the company.
Excellent teamwork skills with proven ability to cultivate collaboration within group and across multiple disciplines to ensure project success.
Strong time-management skills.
Professional interactions in office and with customers and vendors.
Excellent documentation skills.
Ability to multi-task and prioritize with flexibility required in a start-up environment.
Able to balance working independently and within a team on a variety of projects.
Proficient in MSWord/Excel/PowerPoint.
Preferred Skills:
Scientific or engineering background preferred.
This 5+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Krysty:
ALPHA'S REQUIREMENT #21-03937 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #LI-KG1
