Identify process improvement opportunities within the QMS implementation approach and recommend ... Bachelor's degree in engineering, Life Sciences, Quality, Business Administration, or a related ...
Identify process improvement opportunities within the QMS implementation approach and recommend ... Bachelor's degree in engineering, Life Sciences, Quality, Business Administration, or a related ...
OCI Architect
Troy, MI · On-site +1
... implementation experience Location: 100% Remote Job Type: Full Time employee, CTH, or Contract ... OCI Data Science: model deployment, JupyterLab environments, ML pipelines, Aqua (AI Quick Actions)
OCI Architect
Troy, MI · On-site +1
... implementation experience Location: 100% Remote Job Type: Full Time employee, CTH, or Contract ... OCI Data Science: model deployment, JupyterLab environments, ML pipelines, Aqua (AI Quick Actions)
$93K - $122K/yr
What do you need to have? - Bachelor's degree in Computer Science, Software Engineering ... implementation direction for complex solutions. - Strong communication skills with the ability to ...
New
$93K - $122K/yr
What do you need to have? - Bachelor's degree in Computer Science, Software Engineering ... implementation direction for complex solutions. - Strong communication skills with the ability to ...
New
Identify process improvement opportunities within the QMS implementation approach and recommend ... Bachelor's degree in engineering, Life Sciences, Quality, Business Administration, or a related ...
Identify process improvement opportunities within the QMS implementation approach and recommend ... Bachelor's degree in engineering, Life Sciences, Quality, Business Administration, or a related ...
Services Specialist Assistant FTS 8-E10 - Menominee
Menominee, MI · On-site +1
$24.03 - $33.09/hr
This position performs a variety of activities to support the implementation of case plan ... Based on operational needs and within established limits, remote work and alternate or hybrid work ...
Services Specialist Assistant FTS 8-E10 - Menominee
Menominee, MI · On-site +1
$24.03 - $33.09/hr
This position performs a variety of activities to support the implementation of case plan ... Based on operational needs and within established limits, remote work and alternate or hybrid work ...
Services Specialist Assistant FTS 8-E10 - Gladwin/Midland
Midland, MI · On-site +1
$24.03 - $33.09/hr
This position performs a variety of activities to support the implementation of case plan ... Based on operational needs and within established limits, remote work and alternate or hybrid work ...
Services Specialist Assistant FTS 8-E10 - Gladwin/Midland
Midland, MI · On-site +1
$24.03 - $33.09/hr
This position performs a variety of activities to support the implementation of case plan ... Based on operational needs and within established limits, remote work and alternate or hybrid work ...
Services Specialist Assistant 8-E10
Battle Creek, MI · On-site +1
$24.03 - $33.09/hr
This position performs a variety of activities to support the implementation of case plan ... Based on operational needs and within established limits, remote work and alternate or hybrid work ...
Services Specialist Assistant 8-E10
Battle Creek, MI · On-site +1
$24.03 - $33.09/hr
This position performs a variety of activities to support the implementation of case plan ... Based on operational needs and within established limits, remote work and alternate or hybrid work ...
Services Specialist Assistant FTS 8-E10 - Shiawassee/Gratiot
Owosso, MI · On-site +1
$24.03 - $33.09/hr
This position performs a variety of activities to support the implementation of case plan ... Based on operational needs and within established limits, remote work and alternate or hybrid work ...
Services Specialist Assistant FTS 8-E10 - Shiawassee/Gratiot
Owosso, MI · On-site +1
$24.03 - $33.09/hr
This position performs a variety of activities to support the implementation of case plan ... Based on operational needs and within established limits, remote work and alternate or hybrid work ...
ITPA12 - Senior Salesforce Application Developer
Lansing, MI · On-site +1
$33.45 - $48.09/hr
Permanent Full Time Remote Employment: Flexible/Hybrid Job Number: 0801-26-21-138AM Department ... implementing computer systems and applications for Child Welfare and State Hospital systems ...
ITPA12 - Senior Salesforce Application Developer
Lansing, MI · On-site +1
$33.45 - $48.09/hr
Permanent Full Time Remote Employment: Flexible/Hybrid Job Number: 0801-26-21-138AM Department ... implementing computer systems and applications for Child Welfare and State Hospital systems ...
What will you do? -Lead the design, development, implementation, and support of AI-enabled ... Bachelor's degree in Computer Science, Software Engineering, Information Technology, Data Science ...
New
What will you do? -Lead the design, development, implementation, and support of AI-enabled ... Bachelor's degree in Computer Science, Software Engineering, Information Technology, Data Science ...
New
Senior Full-Stack BI Architect / Fabric Data Engineer
Ferndale, MI · On-site +1
$62.50 - $83.75/hr
We're seeking a Senior Full-Stack BI Architect / Fabric Data Engineer to design and implement ... Bachelor's or Master's degree in Computer Science, Engineering, Data Science, or a related field ...
Senior Full-Stack BI Architect / Fabric Data Engineer
Ferndale, MI · On-site +1
$62.50 - $83.75/hr
We're seeking a Senior Full-Stack BI Architect / Fabric Data Engineer to design and implement ... Bachelor's or Master's degree in Computer Science, Engineering, Data Science, or a related field ...
Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering ... Hybrid or remote work environment with regular virtual collaboration * Travel required (up to 50 ...
Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering ... Hybrid or remote work environment with regular virtual collaboration * Travel required (up to 50 ...
$111K - $146K/yr
Design, build, test, implement, and support AI-enabled applications, tools, agents, automations ... Bachelor's degree in Computer Science, Software Engineering, Information Technology, Data Science ...
New
$111K - $146K/yr
Design, build, test, implement, and support AI-enabled applications, tools, agents, automations ... Bachelor's degree in Computer Science, Software Engineering, Information Technology, Data Science ...
New
Services Specialist Assistant 8-E10
Lansing, MI · On-site +1
$24.03 - $33.09/hr
This position performs a variety of activities to support the implementation of case plan ... Based on operational needs and within established limits, remote work and alternate or hybrid work ...
Services Specialist Assistant 8-E10
Lansing, MI · On-site +1
$24.03 - $33.09/hr
This position performs a variety of activities to support the implementation of case plan ... Based on operational needs and within established limits, remote work and alternate or hybrid work ...
Autosar Developer - Remote Opportunity
Detroit, MI · On-site +1
Basic Qualifications:- • Bachelor's degree in Electrical Engineering, Computer Science, or ... Implementation experience in years configuration and integration experience in years if any Core ...
Autosar Developer - Remote Opportunity
Detroit, MI · On-site +1
Basic Qualifications:- • Bachelor's degree in Electrical Engineering, Computer Science, or ... Implementation experience in years configuration and integration experience in years if any Core ...
The Symitar Programmer II role is responsible for the development, implementation, and maintenance ... Bachelor's degree in Computer Science, Information Technology, or related field. * Proficiency in ...
The Symitar Programmer II role is responsible for the development, implementation, and maintenance ... Bachelor's degree in Computer Science, Information Technology, or related field. * Proficiency in ...
Stefanini is looking for a Business Systems Analyst (Healthcare) - Remote For quick Apply, please ... an integrated system implementation Preferred * Background in a health care, sciences or ...
Stefanini is looking for a Business Systems Analyst (Healthcare) - Remote For quick Apply, please ... an integrated system implementation Preferred * Background in a health care, sciences or ...
Stefanini is looking for a Business Systems Analyst (Healthcare) - Remote For quick Apply, please ... an integrated system implementation Preferred * Background in a health care, sciences or ...
Stefanini is looking for a Business Systems Analyst (Healthcare) - Remote For quick Apply, please ... an integrated system implementation Preferred * Background in a health care, sciences or ...
Stefanini is looking for a Business Systems Analyst (Healthcare) - Remote For quick Apply, please ... an integrated system implementation Preferred * Background in a health care, sciences or ...
Stefanini is looking for a Business Systems Analyst (Healthcare) - Remote For quick Apply, please ... an integrated system implementation Preferred * Background in a health care, sciences or ...
Advisory Services Analyst - State Health & Medicaid (Remote Eligible)
Ann Arbor, MI · On-site +1
$70K - $90K/yr
Project content may include implementing alternative payment models, developing and maintaining ... sciences, or a related field; or a Bachelors degree and equivalent experience * Experience ...
Advisory Services Analyst - State Health & Medicaid (Remote Eligible)
Ann Arbor, MI · On-site +1
$70K - $90K/yr
Project content may include implementing alternative payment models, developing and maintaining ... sciences, or a related field; or a Bachelors degree and equivalent experience * Experience ...
Remote Implementation Science information
What is the difference between Remote Implementation Science vs Remote Health Program Coordinator?
| Aspect | Remote Implementation Science | Remote Health Program Coordinator |
|---|---|---|
| Required Credentials | Master's or PhD in public health, healthcare, or related fields; knowledge of research methods | Bachelor's degree in health administration, public health, or related fields; experience in healthcare coordination |
| Work Environment | Focus on research, data analysis, and strategy development in healthcare settings | Manage health programs, coordinate activities, and liaise with stakeholders remotely |
| Employer & Industry Usage | Academic institutions, research organizations, healthcare agencies | Hospitals, clinics, public health departments |
Remote Implementation Science professionals focus on applying research findings to improve healthcare practices through data analysis and strategy development. In contrast, Remote Health Program Coordinators manage and coordinate health programs, ensuring smooth operations and stakeholder communication. While both roles work remotely in healthcare, their core responsibilities and required qualifications differ significantly.
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 16 days ago
Getinge rating
9.3
Based on 14 frontline employees who took The Breakroom Quiz
9th of 427 rated machine equipment manufacturers
Job description
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
The Project Manager - Quality and Regulatory will lead and coordinate projects aimed at Quality Management System (QMS) enhancement initiatives. The project manager will serve as the primary driver of project(s) execution across a group of QMS workstreams, coordinating cross-functional teams and ensuring delivery against defined milestones. Key deliverables include the development of project timelines, project team assembly, managing the schedule and maintaining effective communication through the project. This position is defined term for approximately 12 months. While the role is remote, candidates should reside in Eastern Standard Time.
Job Responsibilities and Essential Duties:
- Serve as project manager, owning an integrated schedule, milestone tracking, and status reporting across all QMS workstreams.
- Apply formal PMI-based project management methodology including scope, schedule, risk, issue, and change management disciplines.
- Develop and maintain project-level RAID logs, status dashboards, and executive-level reporting cadence.
- Facilitate reviews and workstream-level working sessions with Quality, Regulatory, Operations, and cross-functional stakeholders.
- Lead project coordination across the following QMS enhancement areas: Product Development Process, Receiving Inspection, Complaints & Vigilance, Validation, Device History Records (DHRs), Inspection & In-Process Controls, Corrective and Preventive Action (CAPA), and Training.
- Support SOP development, gap closure documentation, and audit-readiness activities within scope.
- Develop and present structured status reports to project teams and senior leadership on a defined cadence.
- Escalate risk and issues proactively; recommend resolution paths with supporting analysis.
- Contribute to the ongoing development of PMO tools, templates, and governance processes within Healthmark's program management function.
- Identify process improvement opportunities within the QMS implementation approach and recommend enhancements.
- Collaborate with Quality Assurance and Regulatory Affairs to ensure all project deliverables meet FDA 21 CFR Part 820 / QMSR and ISO 13485:2016 requirements.
- Proficiency in Microsoft Project and/or equivalent project scheduling tools (Smartsheet, Monday.com); strong Microsoft 365 skills (Teams, SharePoint, Excel).
Required Knowledge, Skills and Abilities:
- Expert-level working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR), including its incorporation of ISO 13485:2016 effective February 2026.
- Strong applied understanding of ISO 13485:2016 QMS requirements throughout the device lifecycle.
- Demonstrated hands-on experience with the following QMS process areas: Product Development Process / Design Controls, Receiving Inspection, Complaints & Vigilance / MDR reporting, Validation (IQ/OQ/PQ), Device History Records, Inspection and In-Process Controls, CAPA, and Training.
- Familiarity with ISO 14971 risk management principles and FDA 510(k) / Class II submission processes is advantageous.
- Demonstrated experience leading complex, multi-workstream projects within a formal project management framework (PMI PMBOK preferred).
- Proven ability to develop and manage integrated project schedules, RAID logs, status reports, and steering committee materials.
- Experience managing cross-functional teams in a matrixed organizational environment without direct line authority.
- Excellent written and verbal communication skills; ability to present complex regulatory and project information clearly to both technical and executive audiences.
- Proven ability to influence, align, and lead cross-functional stakeholders without direct supervisory authority.
- Strong organizational skills; detail-oriented with a track record of delivering on schedule in regulated environments.
Minimum Requirements:
- Bachelor's degree in engineering, Life Sciences, Quality, Business Administration, or a related field required.
- Master's degree or advanced technical credential a plus.
- Minimum 5 years of experience in project or program management roles within the medical device industry.
- Minimum 3 years of direct, hands-on experience implementing or managing QMS projects under FDA 21 CFR Part 820 and/or ISO 13485 in a regulated medical device environment.
- Experience in supporting or leading QMS projects for companies undergoing FDA Class I and/or Class II classification transitions or regulatory remediation projects is strongly preferred.
- PMP (Project Management Professional) certification is highly desired.
Quality Requirements:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
- Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
- Attend all required Quality & Compliance training at the specified interval.
- Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.
Environmental/Safety/Physical Work Conditions:
- Primarily office/hybrid environment; use of computer, telephone, and related office accessories to complete assignments.
- May work extended hours during peak milestones or audit preparation cycles.
- Occasional domestic travel may be required (estimated up to 20-25% depending on site-based activities).
- Physical requirements: ability to sit/stand at a workstation for extended periods; occasional lifting up to 20 lbs.
The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The salary range for this position is between $120,160 to $150,000 per year depending on experience and location.
#LI-MV1
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.
About Getinge
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
10,000+ Employees
Headquarters location
Dr Wayne, NJ, US