Senior Quality Engineer

Posted 2 Days Ago
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84070, Sandy, UT, USA
In-Office
Senior level
Healthtech • Defense • Industrial • Manufacturing
The Role
Leads quality engineering for medical device product and process development, including ISO 13485 and FDA QSR compliance, validation protocols, risk management, inspection systems, SPC, DOE, CAPA, audits, and continuous improvement. Serves as a subject matter expert for automated measurement systems and GD&T, drives eQMS and Quality 4.0 initiatives, analyzes quality data, reduces scrap and COPQ, supports customer interactions, and develops site-wide KPIs.
Summary Generated by Built In

 

COMPANY: Apollo Medical Extrusion Technologies, Inc.

POSITION: Sr. Quality Engineer

LOCATION: 8760 South Sandy Parkway, Suite 200, Sandy, UT 84070

JOB DUTIES: Work on quality aspects of the Product/Process Development Process, ensuring compliance with regulatory requirements (ISO 13485, FDA QSR). Develop and execute validation protocols, including Test Method Validation (TMV), Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ). Understand customer requirements and transfer the knowledge to the process development for higher FPY and success of existing and new projects. Maintain Risk Management Files, dFMEAs, pFMEAs, and Control Plans. Support customer calls and be the quality representative in such interactions. Participate in training activities including salaried and hourly employees. Serve as the subject matter expert for programming and validating vision-based and touch-probe CMMs (MicroVu, Keyence, Laserlinc, Zumbach). Work on inspection method development, qualification (TMV, Gage R&R), and statistical analysis (SPC, DOE). Drive automation initiatives, including electronic QMS, Quality 4.0, and electronic SPC implementation. Assist in fixture design and work-holding solutions to optimize measurement processes. Provide training on automated measurement systems and GD&T interpretation. Quality Systems & Continuous Improvement. Investigate customer complaints and NCRs, conduct root cause analysis, and implement corrective/preventive actions (CAPA). Act as a consultant for quality system processes, including supplier quality, internal audits, environmental monitoring, and training. Support process improvements through Lean and Six Sigma methodologies. Make data-driven decisions and coordinate reporting using statistical tools (Minitab, Excel). Ensure compliance with regulatory, customer, and internal quality requirements. Develop site wide KPIs with modern data analytics tools like PowerBI.

Qualifications

REQUIREMENTS: Bachelor’s degree, or foreign equivalent, in Mechanical or Industrial Engineering, or a related field and Five (5) years of experience as a Quality Engineer, Continuous Improvement Engineer, Manufacturing Engineer, Industrial Engineer, or related occupation. Employer will accept a Master’s degree, or foreign equivalent, in Mechanical or Industrial Engineering, or a related field plus three (3) years of experience as a Quality Engineer, Continuous Improvement Engineer, Manufacturing Engineer, Industrial Engineer, or related occupation.

Must have (3) years demonstrated experience in each of the following:

  • Completing lean-six sigma projects resulting in overall improvement of product quality, cost reduction and customer satisfaction.

 

Must have one (1) year demonstrated experience in each of the following:

  • Working with Automated Measurement Systems like vision systems, CMMs etc.
  • Working with Statistical Process Control (SPC).
  • Making quality scrap reduction and continuous improvement.
  • Working with Data Analytics tools including PowerBI, Excel VBA, and Pivot Tables.
  • Implementing and working with an Electronic Quality Management (eQMS) System.

Must have six (6) months demonstrated experience in each of the following:

  • Implementing and tracking Cost of Poor Quality (COPQ) Metrics and successfully reducing such costs.

CONTACT:  Please apply via company intranet and keyword search job code # 000153 to apply

Skills Required

  • Bachelor's degree or foreign equivalent in Mechanical Engineering, Industrial Engineering, or a related field, plus five years of experience as a Quality Engineer, Continuous Improvement Engineer, Manufacturing Engineer, Industrial Engineer, or related occupation.
  • Master's degree or foreign equivalent in Mechanical Engineering, Industrial Engineering, or a related field, plus three years of experience as a Quality Engineer, Continuous Improvement Engineer, Manufacturing Engineer, Industrial Engineer, or related occupation.
  • Three years of demonstrated experience completing Lean Six Sigma projects resulting in improved product quality, cost reduction, and customer satisfaction.
  • One year of demonstrated experience working with automated measurement systems, including vision systems and CMMs.
  • One year of demonstrated experience working with Statistical Process Control (SPC).
  • One year of demonstrated experience in quality scrap reduction and continuous improvement.
  • One year of demonstrated experience with data analytics tools including Power BI, Excel VBA, and Pivot Tables.
  • One year of demonstrated experience implementing and working with an electronic Quality Management System (eQMS).
  • Six months of demonstrated experience implementing and tracking Cost of Poor Quality (COPQ) metrics and reducing related costs.

Spectrum Plastics Group Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Spectrum Plastics Group and has not been reviewed or approved by Spectrum Plastics Group.

  • Retirement Support A 401(k) match is included in the core package for full-time employees. This provides employer-backed retirement savings support beyond base pay.
  • Wellbeing & Lifestyle Benefits Paid Volunteer Time Off, wellness resources, an Employee Assistance Program, and employer‑paid life/short‑term/long‑term disability are part of the offering. These programs extend support for personal wellbeing and community involvement.
  • Healthcare Strength Health and dental coverage are available, with HSA options noted. The overall package is characterized as solid in multiple descriptions.

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The Company
HQ: Atlanta, GA
2,200 Employees
Year Founded: 1949

What We Do

Spectrum Plastics Group is a global leader in the design, development, and manufacturing of specialty medical components and devices, providing solutions from development through scaled manufacturing for medical and other demanding markets.

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