Quality Assurance Specialist

4 weeks ago


Westborough, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time

Katalyst Healthcares and Life Sciences is seeking a highly skilled Quality Investigator to join our team. The successful candidate will be responsible for investigating customer complaints and product issues, as well as providing data and analysis to support quality improvement initiatives.

Responsibilities:

* Interface with customers and internal stakeholders to gather information and resolve quality issues
* Conduct thorough investigations of customer complaints and product issues, including root cause analysis and corrective action planning
* Collaborate with cross-functional teams to implement quality improvements and ensure compliance with regulatory requirements
* Develop and maintain documentation of quality investigations and corrective actions
* Communicate findings and recommendations to stakeholders, including customers and internal teams

Requirements:

* Bachelor's degree in a relevant field, such as quality assurance, engineering, or a life science
* Minimum 7 years of experience in a quality assurance or regulatory role, with a focus on medical devices or pharmaceuticals
* Proven experience with quality management systems, including ISO 13485 and 21 CFR Part 820
* Strong analytical and problem-solving skills, with the ability to interpret complex data and develop effective solutions
* Excellent communication and interpersonal skills, with the ability to work effectively with customers, internal stakeholders, and cross-functional teams

If you are a motivated and detail-oriented professional with a passion for quality and regulatory compliance, we encourage you to apply for this exciting opportunity.



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