Quality Systems Manager

OVERVIEW: The Quality Systems Manager is responsible for facilitating the successful implementation of the Quality Management System in accordance with FDA Quality Systems Regulation, ISO 13485 and other applicable country specific regulations. They are the champion of all major components of the QMS for the Handicare site, including overseeing department personnel in daily activities to support these functions. They will also aid in the development, implementation, and monitoring of electronic systems to enhance the effectiveness of the QMS. Continuous improvement should be an output from the constant QMS feedback loop.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Maintain the company’s Quality Management Systems, ensuring compliance with FDA Quality Systems Regulation, ISO 13485 and other applicable country-specific regulations.
• 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.
• The drive and energy to lead transformative change in the way we approach quality, building quality

expectations into processes and design.

• Maintain a team focused on the identification of issues and root causes, addressing them, and delivering

permanent improvement. Coaching them to continually improve themselves and the business.

• Manage and facilitate corrective and preventive actions ensuring all product-related issues, customer

complaints/accidents, incidents etc., driving through to closure.

• Establish automated reporting on performance against KPI’s.
• Take the lead in any complex investigations as appropriate.
• Lead and manage the internal audit program, conduct internal audits, and drive associated improvement activity.
• Assist in new product introduction from the design stage through to production.
• Responsible for assisting in the coordination and administration of Engineering Change Requests

from engineering to manufacturing for both new products and changes to existing products.

• Assist in ensuring that all activities relative to the engineering change process are performed,

documented, and records maintained - regulatory requirements, process capability/control, quality plans, etc.

• Oversee QA vendor approval.
• Assist in the management of new and existing suppliers, including performance and supplier audit, and

supplier control.

• Implement inspection/audit programs in manufacturing.
• Assist in maintaining QA files of quality records – document control.
• Responsible for the calibration program.
• Set up proper instrumentation to measure and record variables and train employees on the proper use of the instruments.
• Interface with product development, manufacturing, process, and quality personnel as well as with

Handicare sales and marketing to determine product quality specifications.

• Provide all necessary information concerning product parameters and inspection to production personnel.
• Evaluate processes and ensure they are capable of consistently meeting specification requirements.
• Define attributes and sets accept/reject parameters.
• Assist with returned product investigations as needed to understand failure modes and actions required.
• Assist with handling customer complaints and service requests.
• Assist with various Regulatory Activities:
• Develop regulatory strategies for product development and launch of new products.
• Ensure that US and other international regulatory requirements are incorporated as part of the

development process.

• Assist or lead the preparation and maintenance of moderate-complexity regulatory submissions

while maintaining quality standards.

• Prepare responses to standard questions and comments from regulatory agencies and ensure

issues are addressed in a timely manner.

• Understand regulatory processes, guidelines and guidance documents and what they mean to the organization and ensure that they are communicated through regulatory procedures.
• Maintain facility and product registrations and licenses with various regulatory bodies.
• Establish and maintain Technical Files as applicable.
• Compile and maintain regulatory documentation databases or systems.
• Ability to analyze data and information, both numerical and anecdotal to determine a plan of action and

carry it out.

• Hands-on, action-oriented and pays attention to detail.
• Customer/client focused.
• Strong leadership and coaching skills at all levels of the organization.
• Additional duties as requested or required.

COMPETENCIES:

• Knowledge of quality systems related to medical devices – FDA/ISO 13485 or other highly regulated

industries.

• Strong IT skills
• Strong engineering (ideally biomedical engineering) background and education
• Lead auditor qualification
• Excellent interpersonal skills at all business levels
• Good presentation & communication skills
• Great prioritizing and managing high workload.
• Analyzing and interpreting data and good reporting skills

SUPERVISORY RESPONSIBILITIES:

• Responsible for supervision of QA Supervisor and Quality Engineer and ultimate responsibility over QA Inspectors / Technicians (in-process and outgoing quality). This includes the review of associated records.
• Help ensure proper coordination and cooperation with supporting departments and regulatory bodies.
• Assist with personnel discrepancies, as needed.
• Support, as needed, local interdepartmental leadership at Handicare STL US.

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:

• Bachelor’s Degree (B.A. / B.S.) from a four-year college or university in Engineering, Mathematics or

Science; and 7 to 10 years of quality experience with medical devices in an FDA and or ISO-regulated industry; or equivalent combination of education and experience.

CERTIFICATES, LICENSES OR REGISTRATIONS:

• Six Sigma Green Belt certification preferred.

COMPUTER SKILLS:

• Proficiency in Microsoft Word, Excel, PowerPoint, Outlook is required. Intermediate proficiency with

statistical software packages, such as MiniTab and systems development programs such as Visual Studio, Power Automate and Microsoft Forms is preferred.

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 50 lbs., occasionally lift or move 50 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.

I have read and understand the duties of my position:

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

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