Overview
Quality Integration Lead Jobs in Denver, CO at Agilent Technologies
Are you ready to embark on an extraordinary journey with a team that’s revolutionizing healthcare through cutting edge AI technology? Meet Omega Medical Imaging, the trailblazers that design, manufacture, and support AI-driven image-guided interventional systems, reshaping the world of healthcare for hospitals and medical facilities around the globe. Our unwavering dedication to Advanced Endoscopy and Interventional Cardiology makes us the front runners in the realm of high-tech medical technology.
We are looking for an exceptional Quality Assurance Lead to become an indispensable part of our team. If you are detail-oriented, motivated, and passionate about doing your best work, we would love to have you join us and make a real impact in this role.
Key Responsibilities of this Job:
Assure the integrity and validity of all aspects of OMI Quality System (i.e., Work Instructions, Forms and SOPs).
Identify gaps in efficient process workflow and suggest steps for supplier quality process improvement.
Participate in review and sign-off of final inspection and batch records (Device History Records)
Ensure materials and products meet defined product specifications and standards.
Provide clear direction for change and assists in change management.
Document the results of all inspections.
Review, compile, and analyze data/information to prepare reports.
Utilize data monitoring tools to highlight analysis priorities.
Investigate quality issues to identify root causes and ensure issues are addressed and resolved.
Collect, prepare, and analyze data for complaints, corrective action, and process improvement processes.
Play an active role in the development of inspection requirements.
Analyze all customer feedback for trends and continuous improvement.
Motivate people from compliance to commitment; from good enough to great.
Accept responsibility for own safety and that of others.
Assist in defining and improving processes as part of a team.
Facilitate the NCR process and quarantine shelf to ensure timely resolution of non-conforming materials.
Participate in various audits such as ISO, FDA, internal, and any other required audits necessary to maintain regulatory compliance.
Maintain the equipment calibration program by coordinating both onsite and offsite equipment calibrations, as required.
Prepare and present materials/findings both internally and externally.
This is an on-site position, working Monday-Friday from 8:00 – 5:00.
This description in no way states or implies that these are the only duties to be performed by the employee but is limited to what is considered the essential function for the specific job title.
The Ideal Candidate has:
Experience in a regulated environment is required, with the medical device and/or pharmaceutical industry is ideal.
ASQ is helpful but not required.
Must understand current Good Manufacturing Practices (cGMP’s) and have hands-on experience in a quality/compliance capacity.
Must have strong organizational, analytical, and problem-solving skills.
Leadership and managerial skills to ensure development of staff are desired.
Attention to detail, effective communications skills are keys to success, coupled with proficiency with MS-Office Suite, particularly Excel, PowerPoint, and Word.
What We Offer:
Competitive Based Salary
PTO Package
Paid Holidays
401(k) w/Safe Harbor Company Match
Tuition Reimbursement
Medical, Dental, Vision, Disability, and Life Insurance
HSA with Employer Match Contribution
Your journey starts here, where limitless possibilities meet boundless ambition. Ready to join the team and make a significant impact in the world of Advanced Endoscopy and Interventional Cardiology? Apply now and seize this extraordinary opportunity to shape the future of healthcare.
Omega Medical Imaging, LLC is an EOE and DFW.
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Title: Quality Integration Lead
Company: Agilent Technologies
Location: Denver, CO
