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 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. Together, We're in It for Life.

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.

What youll do:

• 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.

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• 2-3+ years of experience in Medical Device industry or related field.
• High school diploma required, bachelors degree in technical or related field preferred.
• 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, desired candidate will have prior work history in MSA, SPC, Mini-tab, Infinity, sterilization, & clean room environment.
• 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.)
• At least two (2) year experience in a supervision and/or management role preferred.
• Demonstrated experience to lead teams and projects and good organizational skills.
• Previous experience in plastic injections molding related environment.
• Knowledge and background in the Medical Device industry preferred.

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

We 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.

Viant 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. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.