Quality Assurance Supervisor

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.

OVERVIEW: The Quality Assurance Supervisor is responsible for supervising Quality Inspectors/Technicians and ensuring that all daily responsibilities are completed per our procedures and company priorities. They are also responsible for carrying out and supporting the complaint and customer feedback, nonconforming product, and vendor evaluation processes, and assists with CAPAs, internal audits, and other Quality responsibilities. This role will work closely with other departments including Procurement, Engineering, and Production to ensure product and process requirements are being met and optimized. Exceptional communication skills and the ability to work well with others will be critical to success within this role.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Team leadership

• Supervise QA Inspectors/Technicians and review their records.
• Manage schedules and cross-training so every responsibility has coverage.
• Delegate tasks based on skill and availability; review performance and address personnel issues.

Inspection and product release

• Make sure receiving, incoming, in-process, and finished goods inspections and tests are completed on schedule, including control unit testing and Easy Air assembly and final testing, with urgent incoming inspections done immediately.
• Review device history records for completeness and serve as release authority for all devices and oversee release by trained inspectors.
• Develop inspection procedures and define attributes and accept/reject parameters
• Conduct regular production audits and confirm work instructions are accurate and followed.

Complaints and returned product

• Coordinate complaint and customer feedback investigations according to priorities set by the Quality Assurance & Regulatory Affairs Manager, and make sure they are documented and communicated.
• Review and approve complaint and feedback receipt documentation.
• Oversee receipt, investigation, service, and disposition of returned product.
• Identify potentially reportable events and escalate them to the Quality Assurance & Regulatory Affairs Manager.
• Make sure root cause analysis is performed and documented; support Risk Analysis updates for new or realized failure modes.
• Assist customers with technical support and warranty inquiries.

Nonconforming product and CAPA

• Manage the nonconforming product process, including disposition and timely NCR closure.
• Coordinate and document vendor returns and product rework.
• Lead root cause investigations and assigned CAPAs.
• Evaluate trends from complaints, nonconformances, and customer feedback and report them to the Quality Assurance & Regulatory Affairs Manager.

Vendors

• Oversee vendor approval, evaluation, and monitoring; review new vendor qualifications; maintain the approved vendor list and documentation.
• Conduct vendor evaluations, audits, and supplier corrective actions as needed.

Calibration and measurement

• Own the calibration program: procedures, schedules, outside calibration vendors, and out-of-tolerance evaluations.
• Set up instrumentation to measure and record variables, and train employees on its proper use.

Process quality and support

• With Engineering, establish Process Control Plans and a Statistical Process Control program, and evaluate process capability.
• Conduct process and software validations as required.
• Audit the preventive maintenance program and perform internal audits as assigned.
• Support Engineering with drawing reviews, product testing, temporary deviations, and change order implementation.
• Facilitate continuous improvement projects.
• Travel to customers and suppliers as needed to resolve quality problems.
• Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

• Supervises QA Inspectors/Technicians.

COMPETENCIES:

• Knowledge of MDSAP, ISO 13485, and FDA quality system requirements.
• Exceptional communication skills and the ability to both write and speak clearly and effectively.
• Comfortable with and capable of communicating successfully with internal and external customers.
• Excellent time management skills and the ability to balance multiple responsibilities.
• High level of initiative to complete tasks accurately, thoroughly, and in a timely manner.
• Able to perform root cause analysis and corrective action; able to use FMEA.
• Able to use basic statistical analysis, including SPC and process capability.
• Understands gauge validation and calibration; experienced in operating inspection equipment such as micrometers and calipers.
• Ability and desire to work closely with others as an effective team player.
• Follows instructions and responds positively to management direction.
• Looks for ways to improve and promote quality across multiple departments and functions.
• Observes quality, safety, and security policies and procedures.
• Takes responsibility for own actions and edits work for accuracy.
• Commits to communicating and coordinating scheduling needs to ensure work is covered.

LANGUAGE SKILLS:

• Ability to read, analyze and interpret documents such as safety rules, operating and maintenance instructions, dimensional drawings/specifications 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:

• Educational or professional background in quality, science, or engineering:
• Bachelor of Science degree (B.S.) from a four-year college or university, or
• 2+ years of experience in quality or a related field.
• Quality engineering experience, such as SPC, process capability, or process control plans, preferred.
• 1+ year of supervisory or lead experience preferred.

CERTIFICATES, LICENSES OR REGISTRATIONS:

• ISO 13485 internal auditor training or Lead Auditor certification preferred

COMPUTER SKILLS:

• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook is required. Proficiency in electronic Quality Management System such as Qualio is preferred.

PHYSICAL DEMANDS:

• The employee may occasionally 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 occasionally lift and or move up to 50 lbs.

WORK ENVIRONMENT:

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

TRAVEL:

• Infrequent (less than 5% of the time). Valid passport and willingness to travel to other company sites or supplier locations as needed to acquire product knowledge or conduct onsite audits is preferred.

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 accommodations or other reasons. The above statements are strictly intended to describe the general nature and level of the work being performed. They are to not be construed as a complete list of all responsibilities, duties and skills requires 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. #SAVARIAPATIENTCARE