Engineer II, QA

Getinge; Merrimack (NH); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401k plan with company match

Paid Time Off

Tuition Reimbursement

Job summary

Getinge is seeking a CAPA Coordinator to provide Quality Assurance support, ensuring timely and effective CAPA activities. This role involves leading CAPA teams, conducting root cause analysis, and managing quality compliance reporting.

Qualified candidates should have a Bachelor's degree in engineering or a scientific discipline, along with at least two years of experience in a medical device or highly regulated industry. This position offers a hybrid work environment and competitive salary range.

Qualifications

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

Responsibilities

• Lead CAPA Request and CAPA teams throughout the CAPA process.
• Perform analysis on new or revised standards to support compliance.
• Assist in external audits as scribe and technical support.

Skills

Attention to detail

Problem-solving skills

Communication skills

Project management

Knowledge of ISO 13485

Statistical analysis

Education

Bachelor's degree in engineering or scientific discipline

Tools

Microsoft Office (Word/Excel/PowerPoint)

Job description

Job Overview

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.

Job Responsibilities

• CAPA
  • 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).
• Quality Compliance
  • 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 Effectiveness (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).
• Other
  • 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.
• 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

• 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.

Salary

Annual Salary of $90K to 110K with 8% STIP

Benefits

• Health, Dental, and Vision insurance benefits.
• 401k plan with company match.
• Paid Time Off.
• Wellness initiative & Health Assistance Resources.
• Life Insurance.
• Short and Long Term Disability Benefits.
• Health and Dependent Care Flexible Spending Accounts.
• Commuter Benefits.
• Parental and Caregiver Leave.
• Tuition Reimbursement.

Equal Opportunity Employer

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.