Are you looking to be a part of an organization that is innovative, collaborative, and cutting edge? Are you the kind of person that likes to be valued for the skills and knowledge that you bring and also be learning something new every day? If so, we are looking for you! We are seeking a highly-motivated Quality Manager to develop and manage quality and compliance for Eccrine Systems’ wearable, non-invasive, sweat-sensing medication monitoring devices. We are open to both experienced candidates and highly motivated individuals looking to advance their career in Quality Assurance.
Job Description: The Quality Manager will be responsible for quality assurance as we move from R&D through Product Development and FDA approval for our medical device/combination products by directing the development, preparation, and management of the QA/QC systems and ensuring all SOPs and best practices are followed. This hands-on position assumes primary responsibility to set-up, manage, monitor, evaluate, and update the Quality Management System. This position will require a collaborative effort with the Company's scientists, engineers, and leadership team. The Quality Manager will be accountable and responsible for driving decisions, implementing objectives, and establishing a Quality System that is fully compliant and ensures safety throughout the life-cycle of our products and processes.
Ensuring the creation, maintenance, and compliant execution of a Quality System to support medical devices/combination products per FDA, ISO 13485, MDSAP regulations.
Managing the site Quality Manual and executing on internal Quality Systems including Document Control, Internal Audits, CAPA, Management Review, Complaint Management, Change Control, etc.
Developing and providing quality-related training to all team members throughout the employee life-cycle (new hires/onboarding, transfers, and annual/continuing education and training).
Ensuring supplier quality including audits, negotiating Quality Agreements, Supplier Corrective Actions, non-conformances, and other supplier oversight activities.
Planning, development, and approval of verification and validation activities, working in conjunction with Product Development and Manufacturing.
Participating in product design reviews.
Providing oversight of product Risk Management files, including Risk Management Planning, Risk Analysis and Risk Management Reports.
Product release to market activities including batch record reviews, deviation management, and verification of product documentation to ensure market compliance prior to release.
Directing and obtaining company and product registration with USFDA and other governing bodies, including ISO 13485 Certification.
Serving as the Quality Management Representative for Eccrine Systems.
Preferred Qualifications and Skills:
Bachelor's degree in science or engineering with at least 3-5 years of experience in quality systems/quality assurance in the medical device industry is preferred.
An in-depth knowledge of medical device/combination product regulations is required.
Requires demonstrated ability and desire to create, implement, and optimize a compliant quality system.
Must have a demonstrated ability to plan, organize, and self-direct toward company and departmental goals in a rapid and effective manner.
Prior knowledge of company, industry, and governmental regulations affecting medical device product and process quality.
Experience with FDA audits is preferred.
Strong interpersonal skills including a proven track record of building and maintaining effective working relationships with teams and industry partners.
An entrepreneurial spirit; enthusiasm and vision about converting cutting edge science into commercial applications.
Employer will assist with relocation costs.
Internal Number: 131
About Eccrine Systems, Inc.
Eccrine Systems, Inc. is a medical device company dedicated to improving health, safety, and productivity through advanced sweat sensing technologies. The Cincinnati-based company is deploying its breakthrough technology platform to enable pharmacoeccrinology, an exciting new field of precision medicine that will enable prescribers to optimize pharmacotherapy more rapidly and cost-effectively through non-invasive measurement of individual drug responses in eccrine sweat.
Eccrine Systems is the first in the world to demonstrate that pharmacokinetics, how your body processes medication, can be measured non-invasively through sweat. Eccrine Systems is developing systems (medical devices and combination products) to derive individual drug response data based on measurement of drug, metabolite, and biomarker levels excreted in locally stimulated sweat. Real-world drug response data will help prescribers personalize dosing to improve patient outcomes and reduce healthcare costs.