Quality Assurance Analyst (QA)
Chek Diagnostics - Indianapolis, IN

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QUALITY ASSURANCE SPECIALIST ** Medical Diagnostic Devices

Chek Diagnostics, a medical diagnostic device manufacturing, is hiring a Quality Assurance Specialist in Indianapolis, IN.

  • Are you a medical device compliance expert with project management and leadership skills?
  • Do you have a passion for quality?
  • And, would you thrive in an entrepreneurial, energetic company that is experiencing consistent growth?

COMPANY:
At Chek Diagnostics, we take great pride in delivering industry-leading point-of-care and home diagnostics to the global health care market. Our focus is the development of diagnostic tests for chronic diseases such as heart disease, diabetes, and other related medical conditions.

With 30% annual growth and strong profitability, we have committed to the ongoing development of innovative products for the early diagnosis and the ongoing management of these diseases; we take the business of supplying the highest quality, most technologically advanced tools possible very seriously. Founded in 1992, Chek Diagnostics is headquartered in Indianapolis, Indiana, USA. Our products are represented in more than 100 countries worldwide.

OPPORTUNITY:
As our Quality Assurance Specialist, you will oversee quality system training, document control and final QA inspection to meet quality requirements and standards. Through vigilance, remain alert to any potential compliance situations and reports such observations to supervisors. Reporting to the Head Quality Assurance, ensure that Quality System Regulations are applied throughout the organization in every process through training and documentation.

KEY ACCOUNTABILITIES:

  • Hands-on involvement and training with the QA team Train quality assurance team.
  • Create, implement, and maintain quality system documentation.
  • Assist in the creation and the archival of design history and validation files.
  • Direct and coordinate performance of final QA inspections of packaged test strips and analyzers.
  • Maintain quality system records and audit device history records.
  • Generate quality assurance reports, including technical files and risk analysis, according to established guidelines and criteria.

SUCCESS FACTORS:

  • Minimum 5 years of documentation or related experience working in a regulated medical industry, preferably the Medical Devices industry
  • A Bachelors degree in Biology, Chemistry, Medical Technology or related field required.
  • Experience with U.S. FDA and ISO regulations preferred.
  • Adept at interfacing with various disciplines in a company.
  • Must have a high level of multi-task management and be able to use program management tools such as MS Excel and MS Project.
  • Detailed oriented and ability to document effectively and completely.
  • Excellent communication skills, both written and verbal.
  • Ability to drive projects to timely completion.

COMPENSATION AND BENEFITS:
Chek Diagnostics will reward your talents with a total compensation package commensurate with experience. You will also receive a generous benefits package including medical benefits, dental, flexible medical spending account, life insurance, LT disability, PTO, and 401(k) retirement plan with company match.

APPLY NOW:
If you are a medical device compliance expert, we encourage you to apply online now. We prefer that you submit an electronic resume via this career site.

To learn more about Chek Diagnostics, please visit www.cardiochek.com.

Chek Diagnostics requests that all candidate or recruiter inquiries be directed to Safari Solutions.

Drew Smith, HR Consultant
Safari Solutions
317-348-0097

Keywords: life sciences, diagnostic, health products, medical devices, diagnostic, diagnostic devices, healthcare, lipids, cholesterol, Roche, Lilly, chemical, chemistry, quality, IVDD, quality, compliance, regulations, evaluations, manager, management, technical manager, clinical trials, tests, product testing, MS Project, ISO, FDA, quality assurance, QA


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