Quality Engineer

3 weeks ago

west valley city, United States Safeguard Global Recruiting Full time

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 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


• Minimum 3-5 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.

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