Overview
Quality Technician Jobs in Lindon, UT at Pure Manufacturing
POSITION SCOPE AND PURPOSE:
Providing engineering and technical support to the Quality Department through application of risk management and QMS policy. This position supports a wide array of activities related to Change Control, NCR/CAPA, Product Surveillance, QMS Improvements, and Risk Management. This position evaluates the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommends where corrections or improvements are indicated.
DUTIES AND RESPONSIBILITIES:
Engineering
o Develops and documents processes for sub-assembly, and product level inspection and testing.
o Creating test procedures and fixtures for characterization, experimentation, and production
o Analyzing and interpreting data
o Designing, developing, testing and modifying products, equipment and devices
· Quality
o Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
o Maintains calibration and preventative maintenance on equipment and tools used within device production.
o Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
o Implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
o Documents non-conforming material and follows through with root-cause analysis, including supplier corrective actions.
o Conducts first-article inspections and establishes incoming inspection methods/criteria.
o Drafts quality assurance documentation and technical reports (e.g. corrective and preventative actions (CAPAs), product non-conforming reports (NCRs), complaint trending and analysis, etc.)
o Completes and/or supports supplier evaluations and supplier audits.
o Works with suppliers and contract manufacturing partners to resolve Quality issues.
o Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
o Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
· Continuous Improvement
o Implement 5S principles to improve workplace organization and efficiency.
o Lead and participate in Kaizen events to drive process improvements.
o Monitor and analyze key performance indicators (KPIs) to identify areas for improvement.
o Promote Lean manufacturing principles to reduce waste and increase productivity.
· Other Duties as Assigned.
SKILL SET:
· Project management and effective time allocation.
· Problem solver.
· Communicate effectively using electronic media and in written and verbal forms.
· Make telephone and direct personal contact with internal and external personnel.
· Make formal presentations to small or large groups.
· Competent in the use of standard software applications such as Microsoft Word and Excel.
PREFERRED REQUIREMENTS:
Bachelor’s Degree in Engineering, Science or technical field with 3+ years of Quality Engineering experience within the medical device industry (advanced degree or other work experience will be considered).
Previous research, co-op, internship, or industry experience (preference for prior medical device experience)
ISO 13485, MDSAP, MDD/MDR experience, knowledge, and familiarity
BENEFITS:
Competitive Salary based on experience
Attractive Bonus Plan
Company matching 401k
Medical/Dental/Vision insurance plans
Vacation and Holiday program
Job Type: Full-time
Pay: $70,000.00 – $80,000.00 per year
Benefits:
401(k) matching
Dental insurance
Employee assistance program
Flexible schedule
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Experience:
Quality Engineering within the medical device industry: 3 years (Preferred)
Work Location: In person
Title: Quality Technician
Company: Pure Manufacturing
Location: Lindon, UT
