The Cove Business Standards Discussion Forums
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Full Time Direct Hire: Entry to Mid-level Quality Engineer in Boulder, CO

Monitor the Elsmar Forum
Courtesy Quick Links

Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services

International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

Ajit Basrur
Claritas Consulting, LLC

International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Some Related Topic Tags
colorado, job openings
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 14th September 2018, 04:11 PM

Total Posts: 20
Look! Entry to Mid-level Quality Engineer in Boulder, CO

Provides Quality Engineering leadership and support to ensure product quality, safety, and compliance with regulatory requirements. Decisions and recommendations made by this position directly impact the quality of marketed products for domestic and international sales.

All successful candidates will work within 21CFR820, and EN ISO13485 (including applicable regional and sub-ISO standards). Additional regulations and standards may apply.

• Maintains compliance with standards and regulations (QSR, ISO 13485, ISO 14971) and drives improvements in Quality System elements.
• Executes elements of the quality system, which may include:
o Complaint process including customer interface, investigation, MDR reporting determination, record keeping and follow-up.
o Technical review of drawings, inspection plans and procedures, Change Notice documentation.
o Reporting statistical information and trend analysis on Quality Data
o Leads quality/process improvement initiatives and participates in internal auditing.
o Works with established written procedures. Participates in writing, changing, and training on procedures.
• Performs supplier audits and works with suppliers to assure quality of incoming materials
• Serves on product development teams and performs and/or advises on key design control activities for new or changed product, including
o risk management through the product life cycle,
o statistical and technical suitability of verification/validation protocols and acceptance criteria.
o requirements traceability through verification and validation.
• Performs failure investigations of products, processes and systems. Implements corrective and preventive action projects as assigned by management.
• Up to 25% Travel.
• Other duties as assigned.

• Bachelor’s degree in Engineering or related technical field
• Four years medical device experience or an engineering role in a similar regulated environment.
• ASQ Certified Quality Engineer preferred. ASQ Certified Quality/Biomedical Auditor desired.
• Six Sigma certification desired.

• Strong communication skills with the ability to effectively present information and respond to questions from managers, coworkers, and customers.
• Strong technical writing, troubleshooting and problem-solving skills.
• Ability to work effectively and professionally in collaborative team settings.
• Proficient with standard business software including Microsoft Word, Excel, Access, and PowerPoint.
• Ability to read and understand engineering drawings in English.
• Proficient in statistical data analysis and presentation
• Experience in regulated systems including 21CFR820, ISO13485, etc. is required.
• Self-directed and proactive individual with a healthy sense of urgency and drive for results.

The employee is regularly required to sit, stand, walk, and reach with hands and arms. Must be able to perform in a normal office environment requiring sitting at a desk and using a computer. Specific vision abilities required by this job include close vision and color vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

email resumes to

Sponsored Links

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off

Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Getting your foot in the door? Entry level QA Maire Career and Occupation Discussions 4 29th August 2013 11:16 AM
Entry Level Quality Engineer Interview Preparation/Advice? PeterLe Career and Occupation Discussions 23 29th March 2013 12:36 PM
What is the entry level position/job in the field of Quality? Ka Pilo Career and Occupation Discussions 14 14th February 2011 06:01 PM
How to determine competence of entry level quality personnel in an accredited lab? CalRich Training - Internal, External, Online and Distance Learning 11 16th June 2006 08:29 AM

The time now is 05:32 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.

Misc. Internal Links

NOTE: This forum uses "Cookies"