Align

Description

QA Manager, Raleigh, NC

JOB SUMMARY:

• The QA Manager is an experienced, hands-on professional within the medical device industry with extensive knowledge of the requirements of FDA Quality System Regulation (QSR); ISO 13485 & 14971; and applicable worldwide regulations (e.g. EU, China, Japan, Brazil, etc.) The individual exercises independent judgment in establishing Quality System methods, techniques and evaluation criteria for meeting quality objectives. The QA Manager sets strategic direction, establishes efficient and compliant processes throughout the organization and has strong communication skills at all levels. This position will manage implementation of the corporate QMS locally and provide quality oversight to functional teams located at the site.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Leadership role in implementation of the Corporate Quality Management System at the site, ensuring all relevant employees are trained.
• As the local Quality System Management Representative, understand and manage cross-functional processes as described within the QMS.
• Where necessary due to site specific requirements, develop and maintain local QMS procedures and activities to ensure that processes and products are in compliance with applicable quality standards and requirements
• Employ QA/QE methodologies in a leadership role for design and development activities at the site.
• Identify quality assurance metrics; analyze and report trends to site Operations management.
• Lead meeting(s) for timely resolution of quality related issues.
• Active participant and provides insight in all stages of design development, V&V testing and design control activities, ensuring QA/QE considerations and requirements are met.
• Should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical documentation where necessary.
• Participate as Quality subject matter expert in the review of product requirements, design requirements, software requirements specifications, and functional specifications
• Participate as Quality Lead in Risk Management activities, FMEAs and ensure compliance to standards and regulations
• Coordinate failure investigation of product complaint and CAPA activities.
• Provide site leadership in preparation for and hosting of regulatory agency inspections
• Primary Quality Lead in review of Design History File for completeness and adequacy for projects managed at the site as part of design review activities.

QUALIFICATIONS

• Ideally, demonstrated success in a start-up, entrepreneurial work environment
• Ability to analyse and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents
• Understanding of software, electrical and mechanical engineering principles
• Excellent verbal and written communication skills
• Effective problem solving skills
• Ability to work as a team player to achieve individual and company success
• Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint and Microsoft Office Project programs
• Demonstrated project management leadership skills and experience
• Proficient in timely review of technical and clinical data

EDUCATION and/or EXPERIENCE

• Bachelor’s Degree in a technical discipline with 6-10 years Quality System related experience in the medical device industry. Three to five years in a Management Role.
• Thorough knowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. Additionally, be familiar with the revised ISO 13485 and new EU Medical Device Regulation.
• Familiar with ISO 62304, Medical Device Software – Software Life Cycle processes
• Familiar with the regulatory submission requirements for Class I & II medical devices

We are an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We also respect your privacy. Our Applicant Privacy Policies can be found here: http://jobs.jobvite.com/align-tech/