The Engineer Quality Assurance 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.
- 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.
ENVIRONMENTAL WORKING CONDITIONS
- Physical Demands: Standing, sitting, walking and lifting. Traveling by car and air.
- Bachelor’s Degree in technical field or equivalent working experience.
- Minimum three (3) years, experience in a similar field. Working knowledge in problem solving methodologies. Excellent oral and written communication skills.
- Demonstrated experience to lead teams and projects. Good organizational skills. Previous experience in plastic injection molding related environment.
- 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.
At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico. 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.