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.
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
- Assess risk level associated with NCRs and escalates to management.
- Assist with various aspects of development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of cGxP activities.
- Initiate communication of due dates for Quality Systems (Unplanned Events, CAPA, Complaints, etc.) to ensure they are completed on time.
- Contribute to various aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events.
Continuous Improvement
- Initiate self-audit checks and evaluates CAPA effectiveness checks.
Inspection Readiness
- Prepare materials for inspection readiness and management review.
Qualifications
Education & Experience
- Associate’s degree in science or engineering with 5+ years’ experience in pharmaceutical/biopharmaceutical industry OR Bachelor’s degree in above fields with 3+ years’ experience in pharmaceutical/biopharmaceutical industry OR Master’s degree in above fields with 1+ years’ experience in pharmaceutical/biopharmaceutical industry.
- Minimum of 5 years of experience in quality engineering within the medical device industry.
- Experience with Design History Records (DHR) and risk management processes.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a team environment and lead cross-functional teams.
- Certification in Quality Engineering (CQE) or related certifications is a plus.
Knowledge
- Working knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA.
- In-depth knowledge of FDA regulations, including 21 CFR 820, and ISO 13485 standards.
- Working knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines.
- Technical and quality background related to pharmaceuticals.
Skills & Abilities
- Attention to detail required.
- Demonstrated excellent interpersonal skills and flexibility.
- Capable of managing multiple priorities in a dynamic, fast-paced environment.
- Technical writing skills.
- Strong organizational skills.
- Ability to build peer relationships.
- Ability to identify root causes of quality issues and implement effective corrective actions.
- Strong project management skills to oversee quality initiatives and ensure timely completion.
- Excellent verbal and written communication skills to effectively collaborate with cross-functional teams.
Physical Requirements
- Routine office work (sit/stand); no travel requirements.
