ABOUT spencer®

spencer Health Solutions (www.helloimspencer.com) is transforming healthcare by moving care delivery to the home through the company’s spencer® medication adherence and engagement platform. The spencer FDA Class I technology enables virtual care by connecting patients, clinicians, pharmacists and family members digitally.

The Morrisville company offers the right candidate an opportunity to be part of a high-performing team in the development of cutting-edge medical technology at the exciting point of market entry through leading health technology distributors in the US, Canada and Europe.

SUMMARY

The Quality Assurance Specialist is responsible for supporting and maintaining commercial class I and class II medical devices and an ISO 13485 certified quality management system.

RESPONSIBILITIES

• Lead Quality and Regulatory activities in support of class I and class II medical devices.
• Responsible for working with Engineering/Operations/Contract Manufacturer to develop and document
• processes and drive process improvement
• Responsible for customer complaint investigations, corrective action implementation, effectiveness reviews,
• non-conformance resolution, and the internal audit program
• Responsible for routine regulatory filings and reporting
• Assist internal and supplier audits and work with management to resolve timely closure of audit findings
• Initiate, review, and approve change orders
• Participate in risk analysis
• Support the review and approval of new vendors and the maintenance of existing vendors
• Lead activities related to department objectives and company initiatives
• Manage equipment calibration and preventative maintenance programs

REQUIREMENTS

• Bachelor’s degree in engineering/science/software and 5 years of industry experience or
• Certified ISO 13485 lead auditor (preferred)
• Industry certification desired
• Ability to write standard operating procedures, audit reports, and support regulatory submissions.
• Experience with software medical devices desired
• Experience with UDI and Canadian and EU Labeling requirements desired
• Ability to effectively communicate about projects throughout the organization
• Arena, JIRA, and/or NetSuite experience desired
• Strong understanding and application of 21CFR820, 21CFR801, ISO13485, CMDCAS, SOR/98-282,
• 93/42/EEC-MDD
• Ability to train and provide guidance to other departments
• Effective problem solving skills; start-up environment

spencer Health Solutions is an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and the basis of disability or any other federal, state or local protected class.