1 week ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Looking for a senior operations quality engineer for six months from the beginning of June. The scope of work for this role is to support the current senior operations quality engineer on a product transfer project from another site to this facility. Specifically, I'm looking for a person who can, Review risk management files (pFMEA). Review process validation protocols and reports. Draft/update the master validation plan. Review manufacturing process instructions. Draft quality inspection procedures. Review equipment introduction, calibration, and PM records.

Apply fast, check the full description by scrolling below to find out the full requirements for this role.

About

Responsibilities:

Looking for a senior operations quality engineer for six months from the beginning of June. The scope of work for this role is to support the current senior operations quality engineer on a product transfer project from another site to this facility. Specifically, I'm looking for a person who can, Review risk management files (pFMEA). Review process validation protocols and reports. Draft/update the master validation plan. Review manufacturing process instructions. Draft quality inspection procedures. Review equipment introduction, calibration, and PM records.

Requirements:

Bachelor's degree in engineering (Mechanical, Biomedical, Industrial, or related field) or equivalent experience. 5+ years of quality engineering experience in a medical device manufacturing environment (Class II preferred). Strong knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971 (Risk Management), and ISO 14644 (Cleanrooms). Hands-on experience with CAPA, NCMR investigations, root cause analysis, and statistical process control (SPC). Proficiency in Process Validation (IQ, OQ, PQ), Gage R&R, and AQL sampling plans. Ability to interpret engineering drawings, GD&T, and work with metrology tools (calipers, micrometers, CMM). Prior BMRAM and Propel experience is a plus.

Nice-to-have skills

Root Cause Analysis San Jose, California

Work experience

QA QA Manual Test QA Test Automation

Languages

English Seniority level Seniority levelMid-Senior level Employment type Employment typeFull-time Job function Job functionEngineering and Information Technology IndustriesTechnology, Information and Internet Referrals increase your chances of interviewing at TieTalent by 2x Sign in to set job alerts for “Senior Operations Engineer” roles.Manager, Operations Engineering and Inventory Menlo Park, CA $213,000.00-$293,000.00 2 weeks ago Manager, Operations Engineering and Inventory Fremont, CA $213,000.00-$293,000.00 2 weeks ago Menlo Park, CA $128,000.00-$187,000.00 2 weeks ago Business Operations Manager - Capacity Planning Menlo Park, CA $159,000.00-$225,000.00 2 weeks ago Fremont, CA $147,000.00-$208,000.00 2 weeks ago Palo Alto, CA $208,000.00-$221,000.00 3 weeks ago Senior Operations Manager, Central Operations Mountain View, CA $120,000.00-$150,000.00 2 days ago Sr Operations Manager (Mon-Fri 8:30am-5:00pm) Sunnyvale, CA $138,000.00-$196,000.00 1 week ago Mountain View, CA $80,000.00-$120,000.00 2 weeks ago Senior Operations Manager, Fortress Operations Mountain View, CA $120,000.00-$150,000.00 2 weeks ago Mountain View, CA $110,000.00-$150,000.00 2 weeks ago Mountain View, CA $120,000.00-$150,000.00 2 weeks ago Mountain View, CA $80,000.00-$120,000.00 1 week ago Sr. Business Operations and Strategy ManagerSenior Manager, Manufacturing and Operations Sunnyvale, CA $208,000.00-$293,000.00 1 week ago Menlo Park, CA $145,000.00-$204,000.00 2 weeks ago Mountain View, CA $80,000.00-$120,000.00 1 week ago San Jose, CA $150,000.00-$190,000.00 2 weeks ago Senior Operations Manager, Air Data Migrations Mountain View, CA $120,000.00-$150,000.00 2 weeks ago San Francisco Bay Area $140,000.00-$160,000.00 1 month ago Senior Customer Success Operations Manager, BI and Insights Santa Clara, CA $160,000.00-$270,250.00 1 day ago Sr. Operations Manager, Strategic Accounts Mountain View, CA $110,000.00-$140,000.00 2 weeks ago Senior Manager, Business Operations, Viewer Product Mountain View, CA $80,000.00-$120,000.00 2 weeks ago Redwood City, CA $130,000.00-$200,000.00 1 week ago Senior Operations Manager, RCM Eligibility Mountain View, CA $120,000.00-$150,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr