What are the responsibilities and job description for the Sr QA Engineer position at Endo International?
Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.
Job Description Summary
The Senior Quality Assurance Engineer will be responsible for ensuring the quality and compliance of medical devices. This position involves overseeing and managing the Device History Records (DHR), design control, risk management, and regulatory compliance activities, particularly focusing on 21 CFR 820 and other relevant standards. The ideal candidate will have experience in quality engineering within the medical device industry and a strong understanding of regulatory requirements.
Job Description
Responsibilities
Quality Documentation / Report Review
- Oversee and manage Design History Records (DHR) to ensure compliance with 21 CFR 820.
- Implement and maintain quality systems in accordance with FDA regulations and ISO standards.
- Conduct risk management activities, including risk assessments and mitigation plans.
- Lead and support internal and external audits to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to ensure quality objectives are met throughout the product lifecycle.
- Provide guidance and training to quality staff and other staff on quality and regulatory requirements.
- Develop and implement quality policies, procedures, and best practices.
- Monitor and analyze quality performance metrics and implement corrective actions as needed.
- Ensure timely and effective resolution of quality issues and non-conformances.
- Stay updated on industry trends and regulatory changes to ensure ongoing compliance.
- Manage all quality-related issues within the manufacturing team (e.g., internal, supplier, customer, and customer warranty).
- Identify root causes and engineer corrective actions for product quality issues.
- Carry out product and process auditing.
- Ensure control plans and associated documentation are implemented effectively and maintained.
- Participate in the development and refinement of Design and Process FMEA's (Failure Mode and Effects Analysis).
- Lead quality audits and ensure compliance with the Quality Management System (QMS).
Quality Systems
Continuous Improvement
Inspection Readiness
Qualifications
Education & Experience
Knowledge
Skills & Abilities
Physical Requirements
Commitment to Diversity, Equity, and Inclusion :
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
EEO Statement :
At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
