Top 50 Coordinator mdr Jobs

Engineer II, QA
Getinge —Merrimack, NH
- $90,000 - $110,000 a year
- Extended hours
- Microsoft Excel
- Microsoft Outlook
- Engineering
- Commuter assistance
- Disability insurance
Sr. Engineer, QA
Getinge —Merrimack, NH
- $95,000 - $120,000 a year
- Extended hours
- Microsoft Outlook
- Engineering
- Office
- Commuter assistance
- Disability insurance
Regulatory Affairs Specialist II (Need IVDD / IVDR and/or strong EU MDR experience)
Entegee —Orange County, CA
- $45 - $50 an hour
- Full-time
- Hybrid work
- Mid-level
- 3 years
- Bachelor's degree
- Commuter assistance
- Disability insurance
Quick Apply
Documentation Control Coordinator (Contract)
TransMedics, Inc. —Andover, MA
- Full-time
- Mid-level
- Office
- 3 years
- Employee stock purchase plan
- Disability insurance
Quick Apply
Off-Shift Director (Full-Time, Evenings)
Unity Hospital of Rochester —Rochester, NY
- $40.50 - $57.69 an hour
- Full-time
- Nursing
- RN License
- Nursing home
- Tuition reimbursement
Quick Apply
4d
Senior Clinical Trial Manager
Oura —Remote
- $117,300 - $169,000 a year
- Remote
- 5 years
- Travel
- Mentoring
- Paid holidays
- Health insurance
11d
Project Coordinator
W-Industries of Texas, LLC —Spring, TX
- Full-time
- Hybrid work
- Microsoft Outlook
- English
- Mid-level
- Health savings account
- AD&D insurance
Quick Apply
Sales Data Coordinator
Sazerac Company —Louisville, KY
- Hybrid work
- Microsoft Outlook
- Mid-level
- Office
Quick Apply
7d
Quality Control Coordinator
Advance Medical Designs Inc. —Marietta, GA
- Full-time
- Spanish
- Laboratory experience
- English
- Paid holidays
- Health insurance
Quick Apply
Entry-level Health & Safety Coordinator
Woodard & Curran —Butte, MT
- $47,000 - $60,000 a year
- Full-time
- Ability to lift 50 pounds
- Travel
- US work authorization
- Paid parental leave
- AD&D insurance
Quick Apply
Specialist II Post Market Surveillance (United States)
Cordis —Miami Lakes, FL
- Full-time
- Microsoft Word
- Computer literacy
- English
Care Coordinator - SJ
St. Joseph's/Candler —Savannah, GA
- Part-time
- Nursing
- Hospital
- Inpatient
- Paid time off
Warehouse Coordinator IV
Yusen Logistics —Charleston, SC
- Full-time
- Background check
- Microsoft Excel
- Microsoft Access
- Commuter assistance
- AD&D insurance
Staff Quality Systems Specialist I
BD —Franklin Lakes, NJ
- $135,500 - $216,800 a year
- Bachelor of Science
- Children
- Older adults
- Wellness program
- Commuter assistance
12d
Calibration Coordinator
Ascential Medical & Life Sciences —Ham Lake, MN
- $34 an hour
- 7 years
- Engineering
- High school diploma or GED
Quick Apply
Study Start Up Associate II - Medical Device - Arden Hills, MN
ICON Plc —Minnesota
- $62,376 - $77,970 a year
- Full-time
- Customer service
- English
- Mid-level
- Disability insurance
- Health insurance
3d
Labeling Specialist
Teleflex —Maple Grove, MN
- $69,700 - $89,600 a year
- Engineering
- English
- Mid-level
- Disability insurance
- Health insurance
7d
Monitoring Oversight Lead (Lead CRA)
Artivion —Kennesaw, GA
- Remote
- Data entry
- Recruiting
- Senior level
Quick Apply
Senior Associate, Security Operations
Andersen —San Francisco, CA
- $115,000 - $130,000 a year
- Full-time
- Computer science
- Computer Science
- 5 years
- Paid holidays
- Health insurance
Patient Care Coordinator
MDR Specialty Pharmacy —Encino, CA
- $21.50 an hour
- Full-time
- Typing
- Entry level
- Under 1 year
- Paid holidays
- Health insurance
12d

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Engineer II, QA

Getinge -
Merrimack, NH

Apply Now

Job Details

Full-time
$90,000 - $110,000 a year

Benefits

Commuter assistance
Caregiver leave
Disability insurance
Health insurance
Dental insurance
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Vision insurance
401(k) matching
Flexible schedule
Life insurance

Qualifications

Incident investigation techniques for hazard identification
Statistics
Report preparation
Microsoft Excel
Microsoft Outlook
Data mining
Defect resolution root cause analysis
Accreditation standards (regulatory compliance area)
ISO standards
Preventive action implementation
Quality control preventive actions
Corrective and preventive actions (CAPA)
Internal investigations
Schedule management
Quality risk management
Attention to detail
Physics
Microsoft Teams
Leading team collaboration initiatives
Chemistry
Design controls
Biomedical regulatory compliance
Managing projects
Cross-functional team management
Cross-functional communication
FDA regulations
Failure analysis
Excel data analysis

Full Job Description

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

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

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 and Essential Duties

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 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).

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..

Supervision/Management Of Others:

Not Applicable

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

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

INDYLA

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Benefits at Getinge:

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

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

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.

Pay: $90,000.00 - $110,000.00 per year

Benefits:

401(k) matching
Dental insurance
Flexible schedule
Health insurance
Life insurance
Paid time off
Tuition reimbursement
Vision insurance

Work Location: In person

Apply Now

Refine Your Search

coordinator mdr jobs

Engineer II, QA

Sr. Engineer, QA

Regulatory Affairs Specialist II (Need IVDD / IVDR and/or strong EU MDR experience)

Documentation Control Coordinator (Contract)

Off-Shift Director (Full-Time, Evenings)

Senior Clinical Trial Manager

Project Coordinator

Sales Data Coordinator

Quality Control Coordinator

Entry-level Health & Safety Coordinator

Specialist II Post Market Surveillance (United States)

Care Coordinator - SJ

Warehouse Coordinator IV

Staff Quality Systems Specialist I

Calibration Coordinator

Study Start Up Associate II - Medical Device - Arden Hills, MN

Labeling Specialist

Monitoring Oversight Lead (Lead CRA)

Senior Associate, Security Operations

Patient Care Coordinator

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