What are the responsibilities and job description for the Quality Assurance Supervisor position at Span-America Medical Systems Inc?
OVERVIEW: The Quality Assurance Supervisor is responsible for supervising Quality Inspectors 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:
- Supervising Quality Inspectors and ensuring all responsibilities are completed on schedule
- Establishing priorities for complaint investigations and overseeing that they are conducted, documented, and communicated internally as required
- Monitoring incoming product and ensuring that urgent inspections are conducted immediately
- Managing employee schedules so that no responsibilities go without coverage when needed
- Delegating tasks as they arise based on skill and availability
- Reviewing employee performance and addressing any personnel issues identified
- Coordinating complaint investigations according to priorities set by the Quality Systems Manager, and ensuring they are conducted, documented, and communicated internally as required.
- Reviewing and approving complaint and feedback receipt documentation
- Overseeing that customer returns are received in and delegated appropriately
- Identifying and escalating potentially reportable events, communicating incident information to the Quality Systems Manager and Director of Quality, and supporting the submission of regulatory reports as required
- Ensuring complaint investigations are completed in a timely manner and that root cause analysis is performed and documented per our procedures
- Working with other departments as needed to facilitate successful resolutions for customers
- Confirming returned product has been dispositioned appropriately per our procedures
- Supporting risk analyses, including identifying new potential or realized failure modes and updating Failure Mode and Effects Analysis (FMEA)
- Lead and support root cause investigations for product complaints, nonconformances, and quality issues, utilizing structured problem-solving and root cause analysis methodologies.
- Working with Operations to identify process failures and/or potential improvements
- Conducting regular Production audits to confirm quality checks are being performed as specified
- Reviewing work instructions to ensure they are accurate and being followed
- Assessing processes to identify potential improvements to quality and efficiency
- Managing nonconforming product process
- Coordinating and documenting vendor returns and product reworks
- Ensuring product is dispositioned and nonconformance reports are closed in a timely manner
- Evaluating trends from complaints, nonconformities, and customer feedback and assisting with the implementation of appropriate corrective actions
- Overseeing vendor approval, evaluation, and monitoring to ensure product conformity
- Reviewing qualifications of new vendors and maintaining vendor log and documentation
- Conducting vendor evaluations including, as needed, vendor audits and corrective actions
- Supporting various Quality processes such as corrective/preventive actions and internal audits
- Conducting process and software validations as required
- Working with Engineering on ad-hoc projects such as documentation and drawing reviews, product testing, temporary deviations, and implementing change orders
- Facilitating continuous improvement projects and acting as support to meeting various company goals
- Additional duties as requested or required
SUPERVISORY RESPONSIBILITIES:
- This position has supervisory responsibilities.
COMPETENCIES:
- 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
- Mechanically inclined, preferably with experience using electronic and pneumatic equipment
- Knowledge of quality system requirements, such as ISO, FDA, etc.
- Experience in the operation of inspections equipment (micrometers, calipers, etc.)
- 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:
- High School Diploma or general education degree (GED)
- Educational or professional background in quality, science, or engineering:
- Bachelor of Science degree (B.S.) from a four-year college or university
- 2 years of experience in Quality or a related field
CERTIFICATES, LICENSES OR REGISTRATIONS:
- None are required. ISO 13485 internal auditor training or Lead Auditor certification preferred
COMPUTER SKILLS:
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook is required. Proficiency in ERP system such as Microsoft Dynamics AX12 and 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