Engineer II, QA

Getinge•Merrimack, NH

76d•$90,000 - $110,000•Hybrid

About The Position

Provide Quality Assurance level support and oversight to Corrective and Preventive Action (CAPA) activities to ensure effective and timely CAPAs. Support other activities within the Quality Compliance department. Drive continuous improvement activities.

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.
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.

Responsibilities

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).
Execute tasks and projects that impact the Quality Management System (QMS) as required.
Perform analysis on a new or revised standard and execute deliverables to support continuous compliance to applicable current standards and regulations.
Perform Verification of Implementation (VOI) and Effectivity (VOE) of corrective actions.
Improve and maintain the QMS in line with ISO 13485, Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and regulatory requirements applicable to the Quality Management System Regulation (QMSR).
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.