Quality Engineer II

Viant Medical is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality life enhancing medical devices. With nearly 6000 associates across 24 locations worldwide we offer a unique combination of small-company service and attention with big-company resources. Together Were in It for 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 youll do:Support and uphold the Viant Values: Customer Oriented Integrity Servant Leadership Own It Teamwork and Be to company policies and Resolution: identification data collection and trend analysis reporting and initiation of corrective and/or preventative actionOpen investigate and close NCRsOpen investigative and close complaintsContinuous Quality Improvement: systems documents software and technical tools. Update procedures as line ownership customer facing roleReporting of internal and external quality problems and ValidationsCoordinates activities between Engineering Manufacturing and Quality including qualification and and improvement of SPC systems sampling plans and statistical of Quality reporting and analysis as of personnel to improve technical skills job knowledge and control plans and -up to QS Management Representative as prepare and execute Internal Audits as Inspectors in Quality Assurance as with other departments as a member of problem-solving Inspectors in Quality Assurance as Quality Manager duties when other duties as assigned by the Quality Viant with customers vendors and outside Document Control functions as deemed AND EDUCATION REQUIREMENTS2-3 years of experience in Medical Device industry or related school diploma required bachelors degree in technical or related field in medical device or other FDA regulated understanding of ISO 9001 ISO 13485 JPAL MHLW Ordinance 169 and or FDA QSR regulatory literate with working knowledge of MS Word Excl and Access desired candidate will have prior work history in MSA SPC Mini-tab Infinity sterilization & clean room with math statistics and reading comprehension. Proficient understanding of QMS. Excellent oral and written communication understanding of Quality System Regulations (Complaint NCR root cause etc.) Functional Quality statistical knowledge (AQL sampling etc.)At least two (2) year experience in a supervision and/or management role experience to lead teams and projects and good organizational experience in plastic injections molding related and background in the Medical Device industry dental and vision benefits-effective on date of hireGenerous paid time off benefits and 10 paid HolidaysCompany-paid life insurance401k plan with company matchLow-cost nutrition and mental health visitsUp to $150-off your gym membership annuallyDiscounted Pet Insurances for your furry friendsAccess to individualized financial planning meetingsEmployee Discount Program with savings on electronics home goods gym equipment and moreDiscounted family caregiving supportWe offer market competitive compensation. Potential salary range for this role is $90k-$105k. Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted by law.