Sr Quality Ops Engineer

Innova Solutions is immediately hiring for a Sr. Quality Ops Engineer

Position type: Full-time Contract
Duration: 6 months
Location: San Jose, CA

As a Sr. Quality Ops Engineer you will:

Job Description

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

Qualification:

• 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.

Qualified candidates should APPLY NOW for immediate consideration. Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you.
Preeti Sehgal


PAY RANGE AND BENEFITS:
Pay Range : $60/hr - $70/hr
Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA Recognized as by Staffing Industry Analysts (SIA 2022)
• ClearlyRated Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website:

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or . Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.