Position Title:  Quality System Specialist                                              

Reports to:      President / COO                                                           

FLSA Status:    Exempt                                                                                                                        

POSITION SUMMARY                                                                  

The Quality System Specialist serves as the lead Quality Management and Medical Device Regulatory Affairs representative for Acorn Stairlifts, Inc. and leads, manages and supports all medical device Quality System and Regulatory activities.

ESSENTIAL FUNCTIONS

• Ensuring compliance with FDA regulations and requirements and provides general FDA regulatory support to the organization.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• Responsible for leading all FDA regulatory affair related activities
• Responsible for ensuring regulatory compliance of internal labelling design control process
• Leads the development and implementation of quality policies, procedures, work instructions, and forms.
• Conducts Management Reviews to monitor the suitability and effectiveness of QMS implementation and applicable regulatory requirements.
• Responsible for regulatory compliance of conformity evaluation activities within the organization
• Coordinate recall or market withdrawal activities as necessary
• Perform supplier quality evaluations and audits and creates or revises purchase agreements
• Participates in monthly supplier quality meetings and manages supplier corrective actions (SCARS)
• Establish, track and present Quality Metrics to support Quality Management Review
• Maintain company quality standards and work with departments to discuss solutions to quality issues
• Ensures that there are no repeat non-conformances from company audits
• Analyze complaints and make recommendations regarding their reportability.
• Determines if complaints were properly investigated, ensure proper root cause analysis was performed, and appropriate corrective action was implemented.
• Receives and reviews the Audit Corrective Action Plan as appropriate; approves or rejects as indicated.
• Identifies areas of regulatory interest for Auditing when new or modified regulations are made public to ensure regulatory compliance
• Performs follow up Audits when Corrective Actions Plans indicate
• Performs post-implementation audits of new or changes processes as needed
• Participate in associated Quality System Regulations (QSR) training
• Observes all health/safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
• Assists with FDA inspection preparation and execution.

SKILLS

• Must have working knowledge of the Quality System.
• Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements.
• Must be able to effectively communicate findings verbally and in writing.
• Must be detail oriented, possess excellent time management skills, be well organized, a self-starter and display a professional demeanour with a high focus on compliance and responsibilities.
• Requires strong MS Office skills and ability to work in other windows based software (i.e. Word, Excel and Power Point)
• Must be able to work independently with minimal supervision.
• Strong interpersonal skills, as this individual works on quality/compliance issues with different departments. Strong problem skills.
• Analytical skills and ability to read and comprehend instruction, correspondence and memos.
• Ability to comprehend and analyse statistical data and regulatory/legal documentation.
• Ability to create and document official company responses to all state/regulatory compliance officials and offices
• Excellent project and time management skills

ATTRIBUTES

• Ability to comprehend and analyse statistical data and regulatory/legal documentation.
• Competency in conflict resolution and ability to deal with a wide range of personalities effectively and neutrally.
• Ability to create and document official company responses to all state/regulatory compliance officials and offices
• Adheres to work schedule

EDUCATION/EXPERIENCE

Experience with Quality System auditing rules and regulations, including planning and implementation 21 CFR 820 a Plus!

Bachelor’s degree and 5+ years’ experience in quality system auditing.

PHYSICAL REQUIREMENTS

Must occasionally lift and/or move up to 10 pounds

Regularly required to sit, speak, and listen; occasionally required to stand, walk, stoop, kneel, crouch or crawl.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT

The noise level in the work environment is usually moderate.

NOTE:  This job description is not intended to be all-inclusive.

***Must have experience with ISO-13485 and/or FDA 21 CFR 820***

**Must have FDA Experience**