Quality Operations Manager
Quality Operations Manager
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Salary Not Disclosed
1 Vacancy
Job Description
Boldly innovating to create trusted solutions that detect predict and prevent disease.
Discover your power to innovate while making a difference in patients lives.iRhythm is advancing cardiac careJoin Us Now!
At iRhythm we are dedicated selfmotivated and driven to do the right thing for our patients clinicians and coworkers. Our leadership is focused and committed to iRhythms employees and the mission of the company. We are better together embrace change and help one another. We are Thinking Bigger and Moving Faster.
About this Role:
iRhythm is currently seeking a Quality Operations Manager for its facility located in Deerfield IL. The Quality Operations Manager will provide quality direction and tactical support to the reverse logistics intake operations and the clinical operations teams. The role is responsible for all aspects of quality compliance and of the site quality management system supporting intake operations and clinical operations. Our work environment is fastpaced with a collaborative atmosphere. Most of all we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for likeminded individuals to join our team today!
Specific job responsibilities include:
- Oversee the management of the daytoday site Quality Operations activities which include:
o Quality Control
o Reverse Logistics including intake operations
o Product quality issues investigations planned deviations and nonconformances
o Complaint Investigations as applicable
o Calibration as applicable
- Responsible for site NonConformance and MRB processes
- Responsible for site calibration processes
- Responsible for the of sitespecific inspection readiness programs
- Define & Monitor Site Quality Operations metrics to drive product and system quality improvements
- Ensures the implementation of site Quality Management system standards and policies in alignment with iRhythms global quality management system.
- Collaborate closely with clinical operations supporting the development of procedures and ensuring appropriate of operating within the quality management system.
- Liaison with the iRhythm Independent Diagnostic Testing Facility (IDTF)
- Collaborate closely with production and supply chain business partners to ensure a robust and fully compliant site Quality Management System.
- Establish and improve systems to monitor and improve site product quality and lead site quality improvement initiatives.
- Participate and or lead/host site external audits such as FDA inspections and Notified Body audits
- Represent area of responsibility in meetings with management.
- Contribute to efforts to maintain a positive quality culture with operations fully acting as a business partners while advocating for patients and customers needs.
- Assume additional responsibilities and performs other duties as assigned.
About You:
- Bachelors degree required in Science Engineering Computer Science or related medical/science/healthcare field; or equivalent experience.
- Minimum of 7 years of professional experience in quality and regulatory roles in the medical device field
- Strong knowledge of medical device GMPs design control and risk management processes and regulations including software as a medical device.
- Previous experience working in highly regulated environments working with regulatory directly with agencies such as FDA and EU Notified Bodies
- Previous knowledge of regulations and standards such as ISO 13485 ISO14971 FDA 21 CFR 820
- Previous experience with participation in and or hosting external regulatory and or thirdparty audits.
- Highlevel analytical skills and ability to focus on detail.
- Proven capacity to collaborate and build positive relationships and trust over time with crossfunctional partners.
- Demonstrated comfort working in a dynamic entrepreneurial environment where strong organizational leadership and communication skills are required to be successful.
Whats in it for you:
This is a fulltime position with competitive salary package and excellent benefits including medical dental and vision insurance paid holidays and paid time off.
IRhythm also provides additional benefits including 401K (w/ company match) an Employee Stock Purchase Plan annual organizational/cultural committee events and more!
FLSA Status: Exempt
As a part of our core values we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds experiences skills and perspectives. iRhythm Technologies Inc. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance we will consider for employment all qualified applicants with arrest and conviction records.
Make iRhythm your path forward.
#LIJR2
Actual compensation may vary depending on jobrelated factors including knowledge skills experience and work location.
As a part of our core values we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds experiences skills and perspectives. iRhythm Technologies Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.
iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures including those who may have any difficulty using our online system. If you need such an accommodation you may contact us at
About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect predict and prevent disease. Combining wearable biosensors and cloudbased data analytics with powerful proprietary algorithms iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care iRhythms vision is to deliver better data better insights and better health for all.
Make iRhythm your path forward. Zio the heart monitor that changed the game.
Required Experience:
Manager
Employment Type
Full Time
