Quality Manager

Job DescriptionJob Description

Part-time to become full-time in six months. Some work can be performed remotely.

Responsible for managing company’s quality system and compliance to US FDA, Health Canada, and European Union medical device regulations and standards.

RESPONSIBILITIES:

· Act as Management Representative for company’s quality system.

· Maintain quality manual, quality plan, quality procedures, and quality forms.

· Develop and measure company’s quality objectives.

· Monitor company’s state of compliance to US FDA, Health Canada, and European Union medical device regulations and standards.

· Review complaints, NCMRs and other quality data for need to perform root cause investigations.

· Collect and analyze sources of quality data for need to initiate corrective or preventive action.

· Open, assign, monitor, approve and close corrective and preventive actions (CAPAs).

· Review complaints for reportable events and file with appropriate regulatory bodies when reportable events are identified.

· Manage FDA and other regulatory body inspections and ISO 13485 assessments.

· Write responses to inspectional reports.

· Create and maintain risk management files.

· Maintain design history files (DHFs) as needed.

· Update and maintain device master records (DMRs).

· Issue device history records (DHRs) and sign off completed DHRs to release finished product.

· Maintain employee training requirements and records.

· Run management reviews and manage action items generated from the reviews.

· Run internal audit program and manage corrective actions related to audit findings.

· Approve engineering change orders (ECOs) and document change orders (DCOs).

· Approve labeling creation and changes.

· Perform health hazard evaluations, when needed.

· Initiate and release quality holds, when needed.

· Initiate and manage field actions, when needed.

· Manage incoming inspections.

· Manage equipment calibration.

· Monitor supplier quality.

· Implement process controls.

· Perform design validations and verifications and process validations.

· Establish and maintain post-market surveillance activities.

· Performs other duties as assigned.

QUALIFICATIONS:

· Bachelor's degree plus medical device quality system experience is required.

· Computer experience with MS Office (e.g., Word, Excel, Outlook, etc.).

· Knowledge statistical techniques used for sampling plans, trending, etc.

SKILLS:

· Self-starter

· Attention to detail

· Professionalism

· Team player

· Self-motivated

· High ethical standards

· Good organizational skills and ability to multi-task

Company DescriptionWe provide aesthetic equipment to Med Spas, Dermatologists, and other Providers.Company DescriptionWe provide aesthetic equipment to Med Spas, Dermatologists, and other Providers.