Sr. Engineer, QA

Job Overview 

Provide Senior Quality Assurance level support and oversight to Corrective and Preventive Action (CAPA) activities and other activities within the Quality Compliance department. Mentor cross functional teams and facilitate activities to ensure effective and timely CAPAs. Drive continuous improvement activities. Supervise/mentor junior level engineers. 

Job Responsibilities and Essential Duties 

• (95%) 

• As a CAPA Coordinator provide senior level quality assurance support and oversight to CAPA activities to ensure effective and timely CAPAs.  

• Guide cross functional teams through the CAPA request/CAPA process. 

• Mentor cross functional teams and facilitate activities.  

• Provide project manager support to ensure CAPA activities and timelines are agreed upon, communicated, managed, and met. 

• Ensure CAPA Request and CAPA activities are performed per procedures and regulations. 

• Guide problem definition and scoping of CAPAs to assure that the CAPAs appropriately address underlying issues. 

• Facilitate investigations and root cause analyses. 

• Guide teams in documenting Effectiveness Check criteria. 

• Perform CAPA Verification of Implementation and Effectiveness Check activities. 

• Process CAPA documentation within the electronic systems. 

• Serve as a facilitator and/or delegate for the CAPA Review Board as needed. 

• Communicate reminders & CAPA actions needed to personnel at all levels within the organization. 

• Lead continuous improvement activities within the CAPA process. 

• Update procedures and other documentation as needed to ensure continued compliance with regulations. 

• Develop and perform CAPA System training.  

• Supervise/mentor junior level engineers. 

• Other (5%) 

• Assist in meeting departmental goals and special projects as assigned. 

• Support external audits in various roles as assigned: scribe, backroom technical support and file preparation. 

• Prepare documentation needed to fulfill requests from customers (internal and external). 

• Perform other duties, as assigned. 

Minimum Requirements 

• Bachelor’s degree in engineering discipline or scientific discipline (e.g. Chemistry, Biology, Physics) or equivalent experience. 

• Minimum 3 years’ experience with CAPA and root cause investigations. 

• Minimum 3 years’ quality or equivalent experience, working in medical device industry or other highly regulated industry, or equivalent experience. 

Required Knowledge, Skills and Abilities 

• Strong communication and organizational skills. 

• High level of attention to detail and accuracy. 

• Demonstrated ability to manage projects involving cross-functional membership. 

• Expertise using root cause analysis techniques.  

• Ability to prioritize and manage key deliverables and work on multiple tasks/projects. 

• Knowledge of Quality Systems, ISO 13485 and FDA requirements.   

• Knowledge of CAPA, NCR, supplier controls, process controls, design controls, verification and validation, and risk management systems.  

• Strong computer skills, including MS Office applications (Word/Excel/Power Point/Outlook/Teams) and statistical software are required. Ability to perform analyze data and interpret results.  

Supervision/Management Of Others: 

• 0-2 direct reports 

• This position includes the hiring, mentoring, development, and management of 0-2 direct reports. 

Internal and External Contacts/Relationships 

• Interaction with all levels of personnel from various functions 

• Interaction with cross-functional teams/departments  

• Interaction with representatives from regulatory agencies and bodies 

Environmental/Safety/Physical Work Conditions 

• Ensures environmental consciousness and safe practices are exhibited in decisions. 

• Use of computer and telephone equipment and other related office accessories/devices to complete assignments. 

• Hybrid office environment 

• May work extended hours during peak business cycles. 

• Occasional work in controlled environment