Senior Engineer, Quality (Complaints)

Job Title: Senior Engineer, Quality (Complaints)

Supervisor/Manager Title: Senior Manager, Quality 

Job Description Summary: Provide support to various areas of the quality management system with emphasis on post-market surveillance (Complaint handling).

Job Responsibilities:

• Performs complaint investigations and analyses of customer returns, documents test results, and supports the global complaint handling system.
• Ensure post market surveillance processes maintain regulatory compliance including supporting MDR, MDD, and EUMDR required activities for post market surveillance.
• Provide support for Corrective and Preventive Actions (CAPA).
• Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post market life-cycle phase.
• Conduct health hazard assessments or IIAs for fielded products.
• Conduct Corrections & Removals assessments.
• Collaborate cross functionally to perform bounding/scoping for field actions and assist in field action related regulatory inquiries.
• Assess risks that were not previously identified, as well as potential risks associated with changes in therapy, systems, products, components, manufacturing processes,
• Collaborate with Medical Safety and other cross-functional members to review and analyze field data, discuss the harm severity sources and estimate the probability or harm occurrence.
• Support Complaint trending and Severity trending signal dispositions.
• Support updates to risk management file throughout product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation.
• Actively communicate findings to Quality, Development, and Operations teams and escalates when the risk profile of a medical device adversely changes.
• Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings.
• Develops, modifies, applies and maintains quality standards and protocol for risk management.
• Makes decisions and proposes solutions based on calculated risks identified through data analysis 
• Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines. 
• Take on other roles required to support continuous improvement within Quality and manufacturing. Serve as a mentor to more junior Quality Engineers on quality engineering-related activities.
• Support elements of the Quality System such as, but not limited to, NCRs, CAPAs and Complaints.

Required Education and Experience:

• Bachelor of Science degree in engineering or relevant scientific subject.
• 4 + years medical device Quality/Regulatory experience in a medical device, pharmaceutical or life sciences technology driven company.
• Experience with nonconformances, investigations, root cause analysis, risk analysis and corrective/preventive actions.
• Must be familiar with 21CFR820, ISO 13485, and ISO14971 requirements.

Skills and Abilities Required for This Job:

• Can identify work priorities and deploy resources to ensure business needs are met.
• Must be able to work effectively and collaborate within cross-functional teams.
• Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non- technical personnel.
• Must have strong project management and documentation skills.
• Must take initiative and have the ability to conduct hands-on work.
• Must possess the ability to handle multiple tasks with high attention to detail.