Quality Engineer II

Full Time
Upland, CA
Posted
Job description
Come join a growing, steady company! Excellent Benefits and a great team to work with.

  • Full Medical, Dental & Vision, 401(k), effective on your 1st day
  • Paid holidays
  • Growth Opportunities
Are you passionate about being part of a Team that will become the most trusted medical device molding and assembly service provider? Are you tired of mundane cubicle Quality roles? Join Team Upland as our Quality Manufacturing Engineer II and realize your full potential as a High Impact member of our Quality team.

Position: The Engineer Quality Assurance 2 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
  • Continuous Quality Improvement: systems, documents, software and technical tools.
  • Reporting of internal and external quality problems and trends.
  • 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.
  • Planning, controlling, and assuring product and process quality.
  • Back-up to QS Management Representative, as assigned.
  • 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 Manager Quality Assurance duties when required.
  • Perform Supervisor Quality Assurance duties when required.
  • Perform other duties as assigned by the Manager Quality Assurance.
  • Represent Accellent with customers, vendors and outside auditors
  • Execute Document Control functions as deemed necessary.
Enviromental Working Conditions:
  • Physical Demands: Standing, sitting, walking and lifting. Traveling by car and air.
Qualifications:
  • Required – Minimum five (5) years experience in a similar field.
  • Working knowledge in problem solving methodologies.
  • Excellent oral and written communication skills.
  • 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.
It is impossible to list every requirement for, or responsibility of, any position. Similarly we cannot identify all the skills a position may require since job responsibilities and the Company’s needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.
#INDHP

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.

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