Quality Engineer II

New employees are eligible for the following benefits effective date of hire!

• Medical, dental, and vision benefits

• Company-paid life insurance and disability benefits

• Generous Paid time off and 10 paid Holidays

• 401k Plan with Company Match

• Tuition Reimbursement

Position Scope/Summary: The Quality Engineer II is primarily responsible for problem identification, data collection and trend analysis, reporting, and initiation of corrective and/or preventive 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.

Position Requirements:

• Problem Resolution: identification, data collection and trend analysis, reporting, and initiation of corrective and/or preventive action

• Open, investigate, and close NCRs

• Open, investigate 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.

• Plan, prepare, and execute Internal Audits, as assigned.

• Alternate Material Review Board and/or Change Control Board QA representative.

• Coordinate with other departments as member of problem solving teams.

• Assist Inspectors in Quality Assurance as needed.

• Perform other duties as assigned by the Quality Manager.

• Represent Viant with customers, vendors and outside auditors

• Execute Document Control functions as deemed necessary.

Physical Requirements:

• Light physical activity performing non-strenuous day-to-day activities of an administrative nature.

• Minimal lifting (20 lbs.), carrying (10 lbs.), bending, pushing/pulling, crawling, climbing, balancing, and prolonged standing. Manual dexterity sufficient to reach and handle items.

• Requires the ability to identify and distinguish colors, judge distance and space relationships (i.e. visualize objects of multiple dimensions), and adjust the lens of the eye to bring an object into sharp focus (microscope, etc.).

• Normally works in a well-lighted, air-conditioned, indoor office setting with adequate ventilation.

• Work requires to close visual acuity to perform activities such as: Preparing and analyzing data and figures, transcribing, viewing a computer screen, extensive reading, visual inspection involving small defects, small parts, and/or machine operation, using measurement devices, and assembly or fabrication of parts at distance close to the eyes.

Education:

• Bachelor's Degree in technical field or equivalent working experience.

Qualifications:

• Required

• Minimum two (2) to three (3) years' experience in a similar field. Working knowledge in problem solving methodologies. 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.)

• Preferred

• At least two (2) year experience in a supervision and/or management role. Demonstrated experience to lead teams and projects. Good organizational skills. Previous experience in plastic injection molding related environment.

• Specialized Knowledge: Working in a 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, Excel, and Access. Desired candidate will have prior work history in MSA, SPC, Mini-tab, Infinity, sterilization, & clean room environment.

Pay range: We offer market-competitive compensation. The potential salary range for this role is $90,000-$110,000 annual salary. 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.

Other details

• Pay Type Salary

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• Upland, CA, USA