Quality Assurance Specialist
2 weeks ago
Company Overview
Performance Health is dedicated to enhancing the quality of life through innovative health solutions. We are currently looking for a Quality Assurance Specialist to become a vital part of our team.
Position Summary
The Quality Assurance Specialist will oversee and manage quality-related tasks, including leading site investigations, handling nonconformance issues, and facilitating quality training initiatives. This role will also involve collaborating closely with operational teams to ensure adherence to quality standards and drive improvements in product quality.
Key Responsibilities
- Oversee nonconformance and corrective action processes to ensure compliance and effectiveness.
- Conduct thorough investigations of customer feedback to identify root causes and determine necessary corrective actions.
- Utilize data analysis to identify opportunities for product quality enhancements in partnership with operational teams.
- Provide guidance on the application of root cause analysis tools and methodologies.
- Support the management of document changes and perform risk assessments related to modifications.
- Lead quality training sessions and coordinate with experts in the field.
- Compile and analyze post-market surveillance data, generating reports and technical documentation.
- Engage in continuous improvement initiatives and participate in value stream mapping activities.
- Establish and document appropriate testing criteria, inspection points, and measurement methodologies.
- Advise on verification and validation processes for equipment and software.
- Assist during audits and inspections conducted by external regulatory bodies.
- Contribute to the design and launch of new products, ensuring quality and compliance expectations are met.
- Manage supplier selection and maintenance through effective audit processes and resolution of defects.
- Perform additional duties as required.
Qualifications
- Bachelor's degree in Engineering or a related field.
- 1-4 years of experience in a quality systems environment within a regulated industry.
- Experience with data analysis tools and problem-solving methodologies.
- Familiarity with regulatory requirements for medical devices or over-the-counter products is preferred.
- Knowledge of validation reports and testing protocols.
- Demonstrated ability to lead cross-functional projects.
Benefits
- Comprehensive healthcare and insurance benefits.
- Retirement savings programs.
- Generous paid time off and family leave policies.
- Wellness initiatives and employee discount programs.
Performance Health is an Equal Opportunity/Affirmative Action Employer. We value diversity and encourage all qualified candidates to apply.
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