Engineer I, QA - Merrimack, NH - Hybrid

At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers - and to save more lives.

Are you looking for an inspiring career? You just found it.

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

Job Overview

Provide Quality Assurance and CAPA support for CAPA Request and CAPA activities.

Job Responsibilities and Essential Duties

(85%) CAPA Support

• Support Quality Assurance department and cross functional teams on CAPA Request and CAPA activities.
• Participate in problem definition, root cause analysis, action planning and implementation activities.  
• Perform CAPA verification of implementation and verification of effectiveness activities.
• Review CAPA records and documentation for completion and accuracy.
• Process CAPA documentation within the TrackWise electronic system.
• Provide CAPA System training.

(10%) CAPA Administration

• Communicate reminders and actions needed to personnel.
• Follow-up on status and verify required tasks are being completed on-time.
• Schedule and facilitate CAPA Review Board Meetings, and other meetings as required, and take meeting minutes.
• Prepare charts using Microsoft Office (Excel, PowerPoint).
• Update electronic (Excel) log sheets related to CAPA.

(5%) Other

• Assist in meeting departmental goals and special projects as needed.
• Provide backroom support for external audits.
• Update procedures and other documentation.
• Perform other duties, as assigned.

Minimum Requirements

• Bachelor's degree in engineering or science discipline, or equivalent experience.

Required Knowledge, Skills and Abilities

• High level of attention to detail and accuracy.
• Strong oral and written communication skills. Ability to prepare and write well written reports.
• Ability to interact and communicate with all levels of personnel from various functions.
• Strong organizational skills with the ability to work on multiple tasks/projects.
• Self-motivated with the ability to work with minimal supervision.
• Ability to comprehend and apply ISO 13485 and FDA requirements.  
• Strong computer skills, including MS Office applications (Word/Excel/Power Point/Outlook).
• Ability to perform data analysis. Knowledge of statistics.
• Problem solving skills.

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

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About us

Getinge is on an excitingtransformation journey constantly looking for new ways to innovate together with our customersto meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to beCO2 neutral by 2025.We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supportstheirpersonal development andcreativity.Our passionatepeople hold our brand promise 'Passion for Life' close to heart.

Ifyoushareourpassionandbelievethatsavinglivesisthegreatestjobinthe world,thenwelook forwardtoreceivingyourapplication and resume. We hope you will join us on our journey to become the world's most respected and trusted Medtech company.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, Vision and Travel insurance benefits
• Registered Pension Plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Hybrid Work Arrangements (where applicable)
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer. Getinge will, at all times, will comply with all applicable human rights and other legislation when considering all qualified applicants for employment. Accommodations are available upon request for candidates taking part in all aspects of the selection process.