Quality Engineer II

Viant•Upland, CA

9d•Onsite

About The Position

The Quality Engineer II is primarily responsible for problem identification, data collection and trend analysis, reporting, and initiation of corrective and/or preventative action for in process, product and equipment related quality issues. This includes responsibility for the quality aspects of qualification and/or validation of molds, products, processes and equipment.

Requirements

2-3+ years of experience in Medical Device industry or related field.
High school diploma required
Working in medical device or other FDA regulated industry.
Comprehensive understanding of ISO 9001, ISO 13485, JPAL MHLW Ordinance 169, and or FDA QSR regulatory requirements.
Computer literate with working knowledge of MS Word, Excl, and Access
Proficient with math, statistics, and reading comprehension.
Proficient understanding of QMS.
Excellent oral and written communication skills.
Solid understanding of Quality System Regulations (Complaint, NCR, root cause, etc.)
Functional Quality statistical knowledge (AQL, sampling, etc.)
Demonstrated experience to lead teams and projects and good organizational skills.

Nice To Haves

bachelor's degree in technical or related field preferred.
desired candidate will have prior work history in MSA, SPC, Mini-tab, Infinity, sterilization, & clean room environment.
At least two (2) year experience in a supervision and/or management role preferred.
Previous experience in plastic injections molding related environment.
Knowledge and background in the Medical Device industry preferred.

Responsibilities

Support and uphold the Viant Values: Customer Oriented, Integrity, Servant Leadership, Own It, Teamwork, and Be Agile.
Adhere to company policies and procedures.
Problem Resolution: identification, data collection and trend analysis, reporting, and initiation of corrective and/or preventative action
Open, investigate, and close NCRs
Open, investigative, and close complaints
Continuous Quality Improvement: systems, documents, software and technical tools. Update procedures as required.
Product line ownership, customer facing role
Reporting of internal and external quality problems and trends.
Execute Validations
Coordinates activities between Engineering, Manufacturing and Quality, including qualification and validation.
Monitoring and improvement of SPC systems, sampling plans and statistical methods.
Cost of Quality reporting and analysis, as required.
Training of personnel to improve technical skills, job knowledge and performance.
Create control plans and PFMEAs.
Back-up to QS Management Representative, as assigned.
Plan, prepare, and execute Internal Audits, as assigned.
Alternate Inspectors in Quality Assurance as needed.
Coordinate with other departments as a member of problem-solving teams.
Assist Inspectors in Quality Assurance as needed.
Perform Quality Manager duties when required.
Perform other duties as assigned by the Quality Manager.
Represent Viant with customers, vendors, and outside auditors.
Execute Document Control functions as deemed necessary.

Benefits

Medical, dental, and vision benefits-effective on date of hire
Generous paid time off benefits and 10 paid Holidays
Company-paid life insurance
401k plan with company match
Low-cost nutrition and mental health visits
Up to $150-off your gym membership annually
Discounted Pet Insurances for your furry friends
Access to individualized financial planning meetings
Employee Discount Program with savings on electronics, home goods, gym equipment, and more
Discounted family caregiving support