Director of Quality Assurance/ Regulatory

SUMMARY

Responsible for reviewing product design, product performance, and processes to meet company quality management objectives within established guidelines. Coordinates with manufacturing, engineering, technical support, customer service, suppliers and customers to meet established quality objectives and to proactively identify and resolve quality issues that may arise. Fully conversant in regulatory affairs to achieve full compliance with government and industry requirements. Ensure that regulated processes and systems are always inspection ready. Oversee the performance of internal and external audits. Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs, etc.

JOB DUTIES

General functions of the role include but are not limited to: Quality Assurance; Strategic Planning; Regulatory Compliance, Strategy and Submission; Process Controls; Quality Management Systems (QMS); Safety Regulations; Quality Controls; Operational Streamlining Policies & Procedures; C-Level Presentations; Agile Methodologies; Contract Administration; Change Management; Audit Management and Oversight; OSHA; FDA; ISO 13485. More specifically:

• Ensures ISO compliance; serves as a representative to and primary contact with ISO registrar; conducts and leads all ISO surveillance and recertification audits; drives development and implementation of ISO systems
• Ensures that the organization’s Quality Management System conforms to customer, internal and current ISO requirements
• Ensures compliance with FDA regulations including cGMP; evaluates complaints for reporting requirements under FDA
• Spearheads remediation initiatives for FDA and ISO compliance
• Schedules, conducts and supervises the internal audits
• Trains, directs, and supports personnel in understanding and meeting quality initiatives
• Designs and monitors the inspection of incoming, in-process and final product to comply with quality standards and metrics
• Maintains necessary records as required by quality management system documentation
• Updates and enforces quality management policies, procedures and practices
• Communicates with suppliers, OEM’s and parent company regarding product certifications, product performance and product quality
• Conducts and leads the annual Management System Review meeting as well as periodic mini-management review meetings relative to monthly quality metrics
• Leads QA/RA/QMS efforts
• Manages CAPA, validation, and technical files; oversees reviews and complaint management
• Coordinates, investigates, and analyzes product complaints and/or safety issues and makes recommendations regarding their reportability and resolution
• Monitors post-production events and reporting of adverse events
• Conducts internal/external audits, supplier development, and Quality Control Development (QCD)
• Manages document controls
• Develops and maintains purchasing controls/ supply chain & supplier quality management
• Develops and maintains production and process controls/process validation/process consistency
• Timely completion of Quality Management activities including CAPA, Deviation, and other quality events as directed
• Independent review of Risk Management Studies and Product Technical Files Document Control, cGMP, GDP, GxP, Complaints and Vigilance
• QMS support, strategy, and project management
• Perform other duties as required or directed by Leadership

EDUCATION

Minimum of Bachelor's Degree in Engineering, Science, or Related Field, or equivalent experience and

training.

SKILLS/REQUIREMENTS

• Strong regulatory and quality knowledge throughout product lifecycle with aspects of effective management and strategy
• ASQ certification preferred/ cGMP knowledge
• Minimum of 8 years performing quality assurance/ regulatory in a manufacturing environment
• ISO 13485 experience and ISO 14971 required
• Demonstrated results and relevant experience in developing and implementing quality assurance policies, plans, and procedures that meet the compliance requirements, operational performance, and financial objectives of the business
• Background and technical knowledge in manufacturing of Class I or II medical devices.
• Experience in communicating with regulatory authorities (e.g., UL, ISO, and FDA)
• Ability to read and understand engineering drawings, documentation and detailed work instructions
• Ability to understand and work with mathematical concepts including algebra, statistics and probability analysis
• Adept at using a computer and Windows related software including Microsoft Office and ERP systems
• This position will be exposed to confidential company information and therefore, is required to sign a noncompete agreement

PHYSICAL REQUIREMENTS

Occasional lifting, up to 25 lbs.

Frequent computer use

Office in a Factory environment