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TalenTrust LLC
Aurora, CO | Full Time
$95k-115k (estimate)
4 Months Ago
Stellar Solutions
Aurora, CO | Full Time
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Stellar Solutions
Aurora, CO | Full Time
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Quality Engineer
TalenTrust LLC Aurora, CO
$95k-115k (estimate)
Full Time | Business Services 4 Months Ago
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TalenTrust LLC is Hiring a Quality Engineer Near Aurora, CO

Job Description

JOB TITLE: Quality Engineer

COMPANY: Fogg System Company Inc

LOCATION: Aurora, CO

Do you want to work for a growing manufacturing company that is committed to providing high quality products to its customers? Do you want to work for a company that values collaboration, technological innovation and continuous improvement? Then we want to talk to you!

Fogg System Company offers IBP Interface Cables and Adapter Cables as well as Pressure and Temperature Probe Simulators for use with Patient Monitors.

We’ve been helping our customers get the correct IBP Cables for almost 50 years. Transducer and Monitor manufacturers, as well as users in Healthcare and Research facilities worldwide depend on our vast experience and broad selection to accurately and promptly identify the correct Cables for their requirements.

Fogg System Company is seeking a Quality Engineer to join their growing team in Aurora, CO.

Position Summary:

This new position is an opportunity to participate in all aspects of production related quality and engineering support at an almost 50-year-old company intent on future growth. Be in the mix as we develop new products and capabilities and bring them to market. Lead the efforts to continually improve our current ISO Quality System and help us integrate new levels of compliance for world markets as we satisfy the needs of current customers.

You will use your engineering and quality background, along with your strong communication skills, to support this low volume / high product mix manufacturing organization with hands on improvements to existing systems, processes, and documents. You will be expected to offer key insights and ideas for solving quality and production problems as they arise. You will take the lead in responding to the needs of customers and regulatory bodies concerning our products, including both internal and external audits. You will also lead efforts with new product verification and process validation, and will work with the supply chain to improve materials quality and to resolve issues as they arise.

 What you’ll be doing:

  • Help transition our current ISO 9001:2015 compliant quality system into an ISO 13485 compliant system.
  • Assist with the maintenance and improvement of current production processes, routers, documents, and assembly work instructions.
  • Assist with bringing new equipment into the production environment to improve efficiency and reduce manual processing efforts.
  • Assess material nonconformances and create corrective action plans.
  • Conceptualize, create, and implement production process tooling and fixtures.
  • Create new documents, procedures, work instructions, and manufacturing aids in support of the Quality Management System.
  • Act as the primary interface for audits and communications with external entities including customers, registrars, and other regulatory bodies.
  • Validate the elements of Product Master and Product History records.
  • Create Quality Management System Reports for management reviews.
  • Manage suppliers and supplier quality to meet requirements and improve production efficiency.

Qualifications and Experience:

  • A Bachelor of Science in Engineering, or the equivalent technical knowledge gained through work experience in the field of Medical Electronics and other medical technologies.
  • Excellent communication skills including English fluency, reading and comprehending technical literature, and superb writing proficiency with the ability to simplify complex concepts and communicate them to others using the written word.
  • Experience creating production instructions and process documents within a comprehensive ISO Quality Management System.
  • A working knowledge of ISO 9001, ISO 13485, 21 CFR 82, and the EU MDR.
  • Familiarization with the requirements of other regulatory requirements such as RoHS, REACH, TSCA, and Prop 65.
  • The ability to develop strong interpersonal relationships with customers, suppliers, management, and other team members.
  • Good problem-solving abilities and an aptitude for applying past experiences to new challenges.
  • Computer proficiency including experience with the suite of Microsoft Office products.
  • Any industry knowledge of patient monitoring technology, manufacturers, and end users would be a definite plus.
  • Experience working with the FDA is a plus.
  • Advanced technical degrees or additional business education would be welcomed.

What we can offer: 

  • A competitive starting salary, estimated to be in $72k - $88k range, determined by education, experience, knowledge, company fit, and abilities of the applicant.
  • A fantastic benefits package that includes:
    • Bonuses around 10% of salary based on company profitability and individual performance
    • $15k annual benefit allowance, which can be used to cover group health insurance costs for you and your dependents, or can be taken as additional salary if your coverage cost is less
    • Generous retirement plan contributions of up to 25% of your salary to a Simplified Employee Pension Plan (SEP), dependent on company profitability
    • Paid Time Off package including 12 PTO days in Year 1, then 15 in Year 2

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$95k-115k (estimate)

POST DATE

11/06/2022

EXPIRATION DATE

12/23/2022

WEBSITE

talentrust.com

HEADQUARTERS

Denver, CO

SIZE

100 - 200

INDUSTRY

Business Services

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The following is the career advancement route for Quality Engineer positions, which can be used as a reference in future career path planning. As a Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Engineer. You can explore the career advancement for a Quality Engineer below and select your interested title to get hiring information.

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