Indianapolis, Indiana, United States · On-site
$60k–$70k/yr
About Us Intersurgical Inc. is a global leader in the fields of anesthesia, respiratory care, and medical device manufacturing. We partner with providers, manufacturers, and other organizations to supply innovative airwa…
Skills: Regulatory compliance, FDA regulations, ISO standards, Complaint documentation, Audit support
Indianapolis, Indiana, United States · On-site
$16/hr
Production Operator - First Shift Make a Difference Every Day & Build Products That Save Lives. At Intersurgical Inc., the work you do matters. We manufacture life-saving medical devices used by healthcare providers arou…
Skills: Product Assembly, Quality Inspection, Packaging, Labeling, Documentation
Indianapolis, Indiana, United States · On-site
$18/hr
Production Operator - Second Shift Make a Difference Every Day & Build Products That Save Lives. At Intersurgical Inc., the work you do matters. We manufacture life-saving medical devices used by healthcare providers aro…
Skills: Product Assembly, Quality Inspection, Packaging, Labeling, Documentation
Indianapolis, Indiana, United States · On-site
$16/hr–$17/hr
Production Operator - Third Shift Make a Difference Every Day & Build Products That Save Lives. At Intersurgical Inc., the work you do matters. We manufacture life-saving medical devices used by healthcare providers arou…
Skills: Product Assembly, Quality Inspection, Packaging, Labeling, Documentation
Indianapolis, Indiana, United States · On-site
About Us Intersurgical Inc. is a global leader in the fields of anesthesia, respiratory care, and medical device manufacturing. We partner with providers, manufacturers, and other organizations to supply innovative airwa…
Skills: Attention To Detail, Time Management, Problem Solving, Organizational Skills, Collaboration
Indianapolis, Indiana, United States • On-site
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The role involves assisting with regulatory activities for US market distribution and maintaining compliance with quality management system regulations. Responsibilities include managing complaint documentation, supporting internal and external audits, and providing SOP training.
Candidates must hold a bachelor's degree in quality, risk management, or a related field and possess 3+ years of experience. Proficiency in FDA and ISO regulatory requirements is required, along with strong technical skills in MS Office and Adobe Acrobat.
Intersurgical Inc. is a global leader in the fields of anesthesia, respiratory care, and medical device manufacturing. We partner with providers, manufacturers, and other organizations to supply innovative airway and medical devices that impact the lives of patients every day.
Driven by our commitment to supply high-quality medical devices, our team works to deliver best in class products to over 60 countries worldwide.
We celebrate our culture of collaboration and communication. We believe in a workplace where everyone can be their full, authentic self.
We welcome and encourage those with diverse perspectives, veterans, and individuals with disabilities to join our team. We are an ambitious and innovative company and look forward to the unique experiences and different points of view.
Primary responsibility is assisting with regulatory activities pertaining to distribution of products in the US market.
Assist with generating and maintaining documentation required to allow products to be marketed domestically as well as to assist with maintaining compliance with QMS regulations.
Must be able to sit, stand and/or walk for extended periods of time. Must be able to lift 25 lbs.
Work conditions: Office Setting
We are passionate about the well-being of others and that begins with caring for our people.
💰Competitive salary
🧠Multiple opportunities to be challenged and step up your career in a fast-growth company
💹401k
🏖️Paid Time Off and holidays
🥼Medical, dental, and vision benefits
👀Much more...
Leading global designer, manufacturer & supplier of high quality medical devices for respiratory care.
Intersurgical is a global designer, manufacturer and supplier of high quality medical devices for respiratory care and support. Our goal is to provide best practice respiratory product solutions for both patients and clinicians, offering quality, innovation and trust. The extensive product range covers the four areas of: • Airway Management • Anaesthesia • Critical Care • Oxygen and Aerosol Therapy Designed for use in emergency prehospital settings, hospitals and home care. Our company and people have over 40 years’ experience within this focussed area and through continuous improvement we are able to provide solutions to meet changing clinical practice and the needs of our customers and their patients. Our integrated approach enables us to provide our customers with the highest standards in design, manufacture, quality and customer care, responding quickly and effectively. All of our products are designed and manufactured with patient safety, comfort and the environment as key considerations and to meet the requirements of international standards. Interact with us: Instagram: www.instagram.com/intersurgical/ Twitter: www.x.com/intersurgical Facebook: www.facebook.com/intersurgical & www.facebook.com/intersurgicaligelairway YouTube: www.youtube.com/intersurgical
Offices: Crane House, Molly Millars Lane, Wokingham, Berkshire RG41 2RZ, GB
Leading global designer, manufacturer & supplier of high quality medical devices for respiratory care.
Intersurgical is a global designer, manufacturer and supplier of high quality medical devices for respiratory care and support. Our goal is to provide best practice respiratory product solutions for both patients and clinicians, offering quality, innovation and trust. The extensive product range covers the four areas of: • Airway Management • Anaesthesia • Critical Care • Oxygen and Aerosol Therapy Designed for use in emergency prehospital settings, hospitals and home care. Our company and people have over 40 years’ experience within this focussed area and through continuous improvement we are able to provide solutions to meet changing clinical practice and the needs of our customers and their patients. Our integrated approach enables us to provide our customers with the highest standards in design, manufacture, quality and customer care, responding quickly and effectively. All of our products are designed and manufactured with patient safety, comfort and the environment as key considerations and to meet the requirements of international standards. Interact with us: Instagram: www.instagram.com/intersurgical/ Twitter: www.x.com/intersurgical Facebook: www.facebook.com/intersurgical & www.facebook.com/intersurgicaligelairway YouTube: www.youtube.com/intersurgical
Offices: Crane House, Molly Millars Lane, Wokingham, Berkshire RG41 2RZ, GB
