Quality Engineer III - Upland, United States - Creators Wanted

Creators Wanted Upland, United States

3 weeks ago

Description

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 III 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.
Lead Material Review Board and CAPA meetings
Coordinate with other departments as 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
Prepare and participate in audits such as Customer, Supplier and FDA Inspections/audits
Preparation of inputs to the management review meeting.

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 five (5) years' experience in a similar field. Certified as Internal Auditor. Proficient knowledge in problem solving methodologies. Proficient with math, statistics, and reading comprehension. Proficient understanding of QMS. Excellent oral and written communication skills.

Demonstrated experience and knowledge of Quality System Regulations (Complaint, NCR, root cause, etc.) Demonstrated 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. Excellent organizational skills. Previous experience in plastic injection molding related environment. Green belt in Six Sigma preferred.

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 $100,000-$120,000 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 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.

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