Our client in San Jose, CA is looking to add to their growing team a Quality Engineering Manager in Manufacturing as a full-time, permanent employee. If you meet the requirements listed below and are interested in learning more, we recommend that you apply to this position and we will be in contact with you soon.
location: San Jose, California
job type: Permanent
salary: $160,000 - 170,000 per year
work hours: 8am to 5pm
- Lead Quality operations for pilot manufacturing site (class II medical devices)
- Develop and provide hands on support to a variety of quality processes: receiving inspection, equipment qualification, calibration, product release, pFMEA development, process validation, non-conformance management, as well as supervision of quality engineers and technicians.
- Ensure that all sustaining and manufacturing activities are carried out in a manner consistent with regulatory requirements
- Lead and establish project plans to ensure Pilot QE deliverables are completed per project schedule
- Support product transfer from pilot to global manufacturing sites.
- Analyze and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations) in a timely manner
- Collaborate with other functional teams (e.g. manufacturing engineering, supplier quality, logistics) to resolve production issues in a compliant and effective manner.
- Support external inspections and audits by the FDA, Notified Body, and international regulatory authorities
- Bachelor's degree in engineering
- 6-10 years relevant quality experience in medical device manufacturing environment (Class II+)
- Direct experience interacting with FDA, Notified Bodies, or other external regulators
- strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
- Solid understanding of statistical techniques
- strong problem-solving, organizational, analytical and critical thinking skills
- Good leadership skills and ability to influence change
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred
- Experience level: Manager
- Minimum 6 years of experience
- Education: Bachelors (required)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.