Quality Systems Manager

SAVARIA PATIENT CARE

Built from a heritage of brands including Span, Handicare and Silvalea, Savaria Patient Care provides products designed for safe patient handling and positive outcomes. Our research and clinically based product portfolio include therapeutic surfaces for pressure management and positioning, a complete range of innovative ceiling and floor lifts and slings. Savaria Patient Care is a division of Savaria Corporation, a global leader in accessibility.

JOB TITLE:

Quality Assurance & Regulatory Affairs Manager

DEPARTMENT:

QUALITY

REPORTS TO:

DIRECTOR OF QUALITY

FLSA STATUS:

EXEMPT

OVERVIEW: The Quality Assurance & Regulatory Affairs Manager is responsible for facilitating the successful implementation of the Quality Management System in accordance with MDSAP, FDA Quality Systems Regulation, ISO 13485 and other applicable country specific regulations and leads the regulatory affairs and document control programs for Savaria Patient Care. They are the champion of all major components of the QMS for the Span America site, including overseeing department personnel in daily activities to support these functions. Continuous improvement should be an output from the constant QMS feedback loop.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Quality management system

• Maintain the company’s Quality Management Systems, ensuring compliance with ISO 13485, MDSAP, and FDA requirements.
• Lead regulatory inspections, ISO audits, and customer audits.
• Act as a change agent for the rapid evolution from a quality control to a quality assurance structure.
• Own the CAPA system: procedure, prioritization, timeliness, and effectiveness checks.
• Administer the internal audit program and schedule; identify, train and develop internal auditors; perform internal audits.
• Own post-production risk management files and review complaint and nonconformance trends for new or changed risks.
• Set quality objectives and metrics; analyze quality indicator trends and report them to management.
• Prepare monthly quality reports and Management Review inputs, and track resulting actions.
• Host external audits and regulatory inspections.
• Train employees on QMS procedures.

Document and change control (Patient Care)

• Administer the Document Control Program: prepare new documents; write or update SOPs, work instructions, and policies; maintain electronic and hard-copy controlled documents.
• Coordinate and administer Engineering Change Orders from engineering to manufacturing for new and existing products.
• Ensure all change activities are performed, documented, and recorded, including regulatory requirements, process capability/control, and quality plans.
• Maintain quality records, including production and inspection records, per retention requirements.

Regulatory affairs (Patient Care)

• Develop regulatory strategies for product development and new product launches.
• Ensure US and international regulatory requirements are built into the development process.
• Lead the preparation and maintenance of regulatory submissions.
• Prepare responses to questions and comments from regulatory agencies and make sure issues are addressed on time.
• Interpret regulations, guidelines, and guidance documents and communicate them through regulatory procedures.
• Maintain facility and product registrations, listings, and licenses with regulatory bodies and authorized representatives.
• Establish and maintain Technical Files as applicable.
• Maintain regulatory documentation databases and systems.
• Determine reportability of events escalated by the QA Supervisor and submit regulatory reports.

Design and product quality

• Participate in design development and design reviews, including product, design, and software requirements, to make sure quality and regulatory requirements are met.
• Work with product development, manufacturing, and Span America sales and marketing to determine product quality specifications.

Leadership

• Supervise and develop the Quality Assurance Supervisor: set goals, review performance, and approve priorities.
• Set priorities for complaint investigations, NCRs and CAPAs.
• Perform other duties as assigned.

COMPETENCIES:

• Thorough understanding of ISO 13485, MDSAP, FDA quality system requirements, and ISO 14971 risk management.
• Thorough understanding of auditing systems; able to train and develop internal auditors.
• Able to perform and coach root cause analysis and corrective action.
• Able to collect, organize, analyze, and report information in a meaningful way.
• Able to lead and manage projects and to lead and develop a direct report.
• Writes clearly and exercises sound, accurate judgment.
• Strong time management across multiple programs.
• Understands and actively participates in company safety policies and procedures.

SUPERVISORY RESPONSIBILITIES:

• Supervises the Quality Assurance Supervisor, with indirect responsibility for QA Inspectors/Technicians.

LANGUAGE SKILLS:

• Ability to read, analyze and interpret documents such as safety rules, operating and quality

instructions and procedural manuals. Ability to write reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.

EDUCATION, EXPERIENCE & TRAINING:

• Associate’s or bachelor’s degree in health science, engineering, or a related field preferred; not required.
• 5+ years of medical device quality experience required, including hands-on work with the QMS, document control, change control, and regulatory registrations or submissions. If no degree in a health science, engineering, or related field, 8+ years required.

CERTIFICATES, LICENSES OR REGISTRATIONS:

• Six Sigma Green Belt certification preferred.
• ISO 13485 Auditor certification preferred, or obtained within 12 months in the role.
• ASQ Certified Quality Auditor (CQA) or RAPS Regulatory Affairs Certification (RAC) is a plus.

COMPUTER SKILLS:

• Proficiency in Microsoft Word, Excel, PowerPoint, Outlook is required

PHYSICAL DEMANDS:

• The employee may frequently stand, walk, stoop, kneel or crouch during shift. Employee will be required to regularly sit, use hand to finger, handle, feel and reach with hands and arms. Employee must be able to regularly lift and or move up to 25 lbs., occasionally lift or move 25 pounds.

WORK ENVIRONMENT:

• This position works in an environment with moderate noise levels.
• Infrequent international travel

TRAVEL:

• This position may travel up to 25% of the time.

Note: Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Critical features of this job are described under various headings above. They may change at any time due to reasonable accommodation or other reasons. The above statements are strictly intended to describe the general nature and level of the work being performed. They are not to be construed as a complete list of all responsibilities, duties and skills required of employees in this position. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Savaria provides equal employment opportunities and consideration to all qualified employees and applicants, including disabled individuals and veterans.

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