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Job: Quality Assurance Manager, Medical Devices, PhotonMD, Morrisville, NC
Quality Assurance Manager, Medical Devices
Morrisville, NC 27560 United States
We are searching for a Mid-level to Senior Quality Assurance Manager that would be responsible for coordinating all of the Quality related activities for a medical device start-up. This self-motivated leader will have a pivotal role in influencing quality and compliance for groundbreaking new medical device technologies. This position would be the cornerstone of quality assurance within our growing company and be involved with implementing quality systems, ensuring compliance with ISO and FDA regulations, managing document control and training, maintaining supplier quality, complaint management and reporting, and more. You would be working directly with Operations, Electrical/ Firmware Engineering, Industrial Design, Marketing, Regulatory and executive management. If you have a passion for medical device quality assurance, disruptive market technologies and love the independence of the startup environment, this opportunity is for you!
Principal Duties and Responsibilities:
-Perform duties on site, on time, and within the Company’s normal business hours listed in the Employee Handbook.
-Facilitate frequent interactions with co-workers and conduct timely problem-solving meetings necessary to address critical and emerging work issues.
-Present a positive attitude to create and maintain productive working relationships with fellow employees and vendors.
-Monitor and advise on the Quality Management System that complies with domestic and international quality system requirements and guidelines.
-Develop and ensure compliance with quality policies and procedures.
-Develop and implement a continuous improvement program for product quality.
-Review and approve process and product changes notices.
-Manage customer complaint records and reporting.
-Manage document and change control systems.
-Manage CAPA process.
-Administer internal and external audit program and assist with ISO and FDA audits.
-BS in Engineering, Life Sciences or related discipline. An advanced degree is a plus.
-Quality Assurance certification and/or Six Sigma Black Belt and/or Lean Manufacturing certification a plus.
-Auditor and/or quality management certification preferred
-Minimum five years experience in an FDA regulated environment required
-Thorough knowledge and understanding of FDA and ISO quality standards
-Experience implementing or administrating MasterControl or other electronic Quality Management System preferred.
-Experience with Customer Service support preferred.
-Honest, flexible, dependable, self-motivated team player with the ability to work autonomously.
-Must be able to work with technical departments to ensure strong regulatory compliance, technical quality, fast turnaround time, and productivity.
-Demonstrated proficiency in technical writing, good documentation practices.
-The ability to analyze data, determine root cause of deficiencies, and provide recommendations for resolution.
-Able to adapt to changes in the work environment, and demonstrate flexibility.
-Out of the box thinker capable of creating new or unique ways of solving problems.
-Strong organizational skills.
-Strong interpersonal skills, effective written and verbal communication, problem solving and decision making skills. The ability to interact with all levels of management and external parties.
-Capable of motivating people, instilling confidence, and achieving results through your work.
-Effectively prioritizes workload and manages time to complete multiple projects within established timelines and goals with minimal supervision in a fast-paced, interrupt-driven environment.
-Proficiency in Microsoft Office applications is required, specifically Microsoft Word, Excel, Outlook, PowerPoint, and SharePoint.
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds. There will be an occasional requirement to work outside of normal business hours, consistent with other Manager-level positions. Some international travel may be required (5-10%).
PhotonMD maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.
PhotonMD is an equal opportunity employer and does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.
Please email resumes to Info@PhotonMD.com
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