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AA Medical · 11 hours ago

Quality Manager

Mokena, IL

Full-time

Onsite

Mid, Senior Level

$90K/yr - $95K/yr

5+ years exp

Mojo Medical is a provider of sustainable solutions to the medical device equipment market. The Quality Manager will ensure that refurbished medical devices meet all necessary quality and regulatory standards, lead audits, and collaborate with cross-functional teams to maintain high product integrity and compliance.

Computer Software

Growth Opportunities

Responsibilities

Ensure that the company complies with all relevant regulations, including FDA (Food and Drug Administration) standards and ISO 13485 requirements for medical devices

Develop, implement, and maintain the Quality Management System (QMS) to meet FDA and ISO requirements for refurbished medical devices

Lead internal and external audits, including FDA inspections and ISO certification audits, ensuring that all processes are documented, and any corrective actions are completed promptly

Collaborate with Acquisitions and Distribution Operations teams to ensure appropriate process and quality controls around incoming materials

Oversee the inspection, testing, and validation processes of refurbished medical devices to ensure compliance with quality and safety standards

Ensure that the organization maintains and adheres to appropriate packaging and shipping processes to ensure delivery of quality products to AA’s customers

Oversee the organization’s RMA process to include Sales Ops appropriate issuance of RMAs, investigation and classification of returned materials, issuance of CAPAs, and report out of results

Management of corporate EHS program for all sites

Maintain control of and documentation for all quality processes, audits, and certifications

Investigate any quality-related issues, perform root cause analysis, and implement corrective and preventive actions to avoid recurrence

Develop and oversee training programs and guidance to employees on quality standards, procedures, EHS, and regulatory compliance

Lead continuous improvement initiatives and Kaizen events to enhance product quality and operational efficiency

Qualification

Quality Management SystemFDA regulationsISO 13485 certificationRoot cause analysisAuditing skillsContinuous improvementTraining developmentSix Sigma methodologyCommunication skillsAttention to detail

Required

Bachelor's degree in Engineering, Life Sciences, or related field

Minimum of 5 years of experience in quality management, preferably in the medical device industry or refurbished medical device sector

Proven track record in conducting and leading audits, including FDA and ISO inspections

Excellent analytical skills with experience in root cause analysis and corrective action processes

Strong verbal and written communication skills, with the ability to interact effectively with internal teams, suppliers, and regulatory bodies

High level of accuracy and attention to detail in managing quality systems and documentation

Preferred

advanced degree preferred

Strong understanding of FDA regulations, ISO 9001 & 13485 certification, and other relevant medical device regulatory requirements experience highly preferred

Certification in Quality Management (such as CQE or CQA) or experience with Six Sigma methodology is a plus

Benefits

Unlimited PTO for exempt employees, so you can take the time you need to recharge and enjoy life outside of work.

9 observed holidays to spend time with loved ones and celebrate important occasions.

3 floating holidays

Medical coverage with HSA and PPO options, so you can choose the plan that works best for you.

FSA and HSA accounts, as well as dependent care FSA, to help you save on healthcare and dependent care expenses.

Discounts on pet insurance to keep your furry friends healthy.

Delta Dental and Delta Vision insurance offerings.

Short term and long term disability coverage through Principal, to provide financial protection in case of unexpected events.

EAP (employee assistance program) through Principal, to provide confidential support and resources for personal and work-related challenges.

Pet friendly office in Mokena, to make your furry friends feel welcome and at home.

4% 401(k) company match after 30 Days

Company

AA Medical

For over ten years, AA Medical Store has consistently exceeded expectations by delivering a white glove experience and high quality equipment customers can count on.

Founded in 2010

Mokena, Illinois, US

201-500 employees