AuST Manufacturing is a rapidly-growing medical device design house and manufacturing facility, with an innovative and energetic team that is committed to providing high-quality products to our customers and patients. We are seeking a Senior Quality Engineer that will be instrumental in applying best practices to ensure that our materials, components, processes, and manufacturing techniques produce high-quality, reliable products that exceed our customers’ expectations.
Key Responsibilities
· Integrate quality into manufacturing processes as a value added (real-time) support function, performing root cause analysis, driving data-based continuous quality improvements, and building strong customer relationships.
· Ensure the successful integration of quality assurance, risk mitigation, and regulatory compliance into device design, development, and manufacturing processes throughout the product lifecycle.
- Participates in design control and evaluates changes to design and/or manufacturing process for impact to DHF. Leads and executes activities to close any gaps, such as additional verification testing or updates to risk documentation.
- Assists with product and process risk assessment activities, including hazard analysis and design/process failure modes & effects analysis (DFMEA/PFMEA).
- Participates in product and process qualification and evaluation activities not limited to but including complaint investigation, first article, engineering studies, gage R&R, regression analysis, SPC, and DOE.
- Develops and implements methods for sampling, inspection, defect recognition, product testing and evaluation, and SPC trending utilizing statistical, engineering and quality knowledge.
- Support the timely handling of investigations, risk assessments, deviations, NCRs and CAPAs.
- Support internal and external audits as a device and QMS Subject Matter Expert.
· Leadership and mentoring responsibility for promoting and implementing best in class Quality Management Systems, manufacturing processes, statistical techniques, and QMS software solutions.
Qualifications
- Bachelor's degree in a scientific or engineering field is required.
- Minimum 3 years' experience in a quality engineering role in the medical device industry, or a related industry with manufacturing & assembly processes.
- Excellent written and verbal communication skills.
- Proficiency with standard office productivity suite and data analysis software, LMS and eQMS software familiarity is a plus.
- ASQ CQE preferred
- High level of competence in statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation, regression, analysis of variance, probability, etc.
- Experience in medical device design control, risk management, validation, and product lifecycle
- Experience with FDA GMP practices, CAPA and non-conforming material processes
- Working knowledge and application of device regulations, including 21 CFR 820, ISO 13485, and ISO 14971. Knowledge of MDSAP, EU MDD/MDR a plus.
- Ability to manage multiple projects within various disciplines, in a fast-paced environment.
- Self-motivated and capable of working cross-functionally with minimal supervision.
- Demonstrated ability to assess and provide technical, statistical, and quality guidance throughout the organization to ensure high quality, compliant products.
- Must be detail oriented with strong leadership skills and excellent interpersonal, collaboration and communication skills.
Job Type: Full-time
Pay: $70,000.00 - $95,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Ability to Relocate:
- West Valley City, UT 84119: Relocate before starting work (Required)
Work Location: In person