What are the responsibilities and job description for the Quality Assurance Specialist II position at Insight Global?
About the Role
As a Quality Assurance Specialist II, you will be responsible for ensuring that all aspects of our Hinge cast product line meet regulatory requirements. This includes developing and implementing process validations, championing compliance, and leading non-conformance investigations.
Responsibilities
- Develop and implement process validations (IQs, OQ/PQs, TMVs) to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to identify and address quality issues.
- Conduct thorough investigations and maintain accurate records of non-conformances.
- Develop and implement corrective and preventive actions to prevent recurrence of quality issues.
Requirements
- Minimum 4 years of experience in medical device manufacturing or other highly regulated industries.
- Strong understanding of process validations, including IQs, OQ/PQs, and TMVs.
- Ability to lead cross-functional teams and collaborate effectively.
- Excellent communication and analytical skills.
What We Offer
We offer a competitive compensation package, including a comprehensive benefits program, opportunities for professional growth, and a dynamic work environment.
Compensation Range
$38-50/hour, based on experience.
Salary : $38 - $50
