Engineer II, Quality Assurance (Hybrid) - Merrimack, NH

HYBRID - Eligible to work from home 1 - 2 days/week.

Job Overview

Provide Quality Assurance support and oversight to Corrective and Preventive Action (CAPA) activities to ensure timely and effective completion of CAPAs.

Job Responsibilities and Essential Duties

• (85%)
  • As a CAPA Coordinator, lead CAPA Request and CAPA teams throughout the CAPA process for successful completion of CAPA activities.
  • Provide project management support to ensure CAPA activities and timelines are agreed upon, communicated, managed, and met.
  • Review CAPA Request and CAPA documentation to ensure CAPA activities are performed and documented per procedures and regulations.
  • Drive problem definition and scoping of CAPAs to assure CAPAs will appropriately address underlying issues.
  • Facilitate and lead failure investigations and root cause analyses.
  • Develop effectiveness check criteria.
  • Perform CAPA verification of implementation and verification of effectiveness activities.
  • Process CAPA documentation within the electronic systems.
  • Communicate reminders of actions needed to personnel at all levels within the organization.
  • Provide training on the CAPA process as needed.
  • Schedule review of CAPA documentation with the CAPA Review Board.
  • Serve as facilitator of the CAPA Review Board meetings and take meeting minutes.
  • Prepare documentation for trending & metrics using Microsoft Office (Excel, PowerPoint).
• (15%)
  • Assist in meeting departmental goals and special projects as assigned.
  • Support internal and external audits.
  • Update procedures and other documentation as needed to ensure continued compliance with regulations.
  • Perform other duties, as assigned.

Minimum Requirements

• Bachelor’s degree in engineering discipline or scientific discipline (e.g. Chemistry, Biology, Physics) or equivalent experience.
• 2+ years’ quality experience or equivalent, working in medical device industry or other highly regulated industry.
• Experience performing root cause investigations.

Required Knowledge, Skills and Abilities

• High level of attention to detail and accuracy.
• Strong problem-solving skills and experience using root cause analysis techniques.
• Strong oral and written communication skills. Ability to prepare well written reports.
• Ability to interact and communicate with all levels of personnel from various functions.
• Ability to manage projects involving cross-functional membership.
• 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).
• Knowledge of statistics. Ability to perform data mining, analyze data and interpret results.

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

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