Manager of Quality Assurance
This is an exciting opportunity for career growth! Applaud Medical is seeking a highly dynamic individual who will be responsible for the oversite of its Quality Assurance (QA) program. This individual will be the Company’s Management Representative and will be responsible for the implementation and management of the Company’s Quality Systems Procedures and Documentation, as well as for providing on-going guidance in the proper implementation of the QA program to the Company’s employees.
The person hired for this position will work closely with the EVP of RA/CA/QA and with Applauds Research, Development and Operations personnel. Applicants should have demonstrated experience with development, implementation and management of company-wide Quality Systems, and hands-on experience with implementing change or upgrades to the Quality Systems used in an organization. Applicants should have highly developed written and oral communication skills. The person hired for this position will be responsible for assuring that Applaud is compliant with all applicable medical device state, federal, and international standards and laws, including FDA’s Quality System Regulations, EU’s Medical Device Regulation, ISO13485and other ISO/EN standards, and AAMI/ANSI standards.
- Maintain up-to-date knowledge of federal, state, local, and international quality system regulations and standards.
- Develop and implement Quality Systems Procedures conforming to 21 CFR Part 820 and ISO 13485. These procedures include but are not limited to:
- Design Controls
- Device Test Verification and Validation Process
- Risk Management Process
- Corrective and Preventive Action
- Complaint Investigation
- Medical Device Reporting and Tracking
- Device Corrections and Removals
- Facility and Equipment Controls
- Material Controls
- Records, Documents, Change Controls
- Production and Process Controls including sterilization process controls
- Management Reviews
- Provide guidance to R&D and Operations in the proper implementation of Design Controls
- Manage Design History Files
- Process Document Change Orders
- Work closely with Operations in generating the protocols and reports as necessary, and conduct process validations, including packaging and sterilization.
- Develop documentation and implement procedures in anticipation of FDA audits and inspections.
- Supervise Document Services and staff (when applicable)
- Administer Employee Performance Evaluations (when applicable)
- Identify and implement continuous process improvement methodologies and tools to effect efficiency change and cost reduction
- Identifies, responds to and resolves general quality issues.
- Perform other activities, as required
- Not applicable
Knowledge and Skill Requirements:
- Must have 7 or more years of quality experience in a medical device company, with 5 years of direct management and quality assurance experience.
- Must have thorough understanding of US FDA Quality System Requirements, ISO 13485, and Europe’s MDR requirements.
- Individual must be a hands-on, results-oriented manager and leader, who is a strong team player, excellent communicator, and comfortable in an entrepreneurial small-company environment.
- Requires strong written, oral, interpersonal, group, and telephone communication skills.
- Position works closely with the EVP of RA/CA/QA, R&D, Operations, and the Company’s contract manufacturers.
- Demonstrated ability to deal with unresolved situations, frequent changes, delays or unexpected events.
- Must be able to follow established policies and procedures, create new procedures, and comply with regulatory requirements.
- Ability to recognize problems, recommend and implement solutions.
- A logical and organized thought pattern is required.
- Computer skills are needed, with experience using Microsoft Access, Word, Excel, PowerPoint, as Egnyte and DocuSign and other project management tools.
- Knowledge of statistics and application of statistical methods and analyses is recommended, as the position requires trend analysis to be performed.
- Experience working with computer-based, software controlled medical devices is preferred.
- The ability to communicate articulately, in English, both verbally and in written materials is required. Foreign language skills are preferable.
- Bachelor's Degree in Engineering or natural or biological sciences, or equivalent BS/MS IE, ME, QA, BME
- CQE, RAC, RAB, or other quality and regulatory certificates are beneficial.