Quality Assurance Specialist II
4 days ago
We are seeking a highly skilled Quality Assurance Specialist II to join our team at Integra LifeSciences. In this role, you will be responsible for ensuring compliance with regulations and internal procedures related to complaint handling.
Key Responsibilities- Investigate and document complaints in a timely and efficient manner
- Evaluate and escalate relevant information to management as necessary
- Coordinate and attend meetings with departments to resolve customer complaint issues
- Develop and execute onboarding training for new complaint associates
- Assess, process, and close complaints in accordance with procedures and customer quality expectations
- Maintain and organize complaint product retention programs
- Conduct technical complaint evaluations and investigations, including failure analysis
- Review quality and manufacturing records to identify trends and risks
- Perform root cause analysis and implement corrective actions
- Establish and maintain quality management system procedures and work instructions
- Support internal and external audits
- Ensure compliance with ISO 13485, MDD, 21 CFR 820, GMP, and other applicable regulations
- Provide data analysis for metric reviews
- Support post-market surveillance activities
- Bachelor's degree in an engineering discipline (e.g. mechanical, electrical) or relevant experience
- Minimum 5 years' experience in a regulated industry (e.g. medical device)
- Strong knowledge of FDA Quality Systems Regulations, GMP, ISO 13485, and other global regulations
- Excellent verbal and written communication skills
- Strong organizational skills with ability to multitask and prioritize
- Ability to read and write in English
Integra LifeSciences is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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