OrthoAccel Technologies, Inc. (OA), founded in 2007 and located in Houston, TX, is a venture-backed medical device company. It is engaged in the development and commercialization of a product-line of dental appliances. Its technology accelerates bone-remodeling to reduce the duration required to complete orthodontic treatment.
The Quality Assurance and Training Specialist reports directly to the Director of Quality Assurance and Regulatory Affairs. Primary responsibility is Training management: Taking complete ownership and driving of the Training function including: new hire Level 1 training; document revision training; annual recertification training; setting up job development training and assisting managers with employee Training Plans. Other responsibilities include assisting in document reviews and internal audits, chairing process improvement initiatives, and acting as a backup to critical Operations functions (Customer Service, Order Processing, and others), as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Employee Training:
o Training company personnel on new procedures, procedure updates, and any other type of training required by the QMS
o Ensures all training is completed timely and per QMS
o Maintaining and updating the organization’s Training Matrix
o Identifying and facilitating job specific training
o Conducting new hire and recertification training
o Working with supervisors/managers to create and approve employee Training Plans
• Internal Audits:
o Participate in the scheduling, auditing, reporting, and CAPA for the Internal Audit process.
o Following up with action item from audit responses (Internal and Supplier Audits)
• Quality Meeting Scribe:
o Take minutes for Quality Department Meetings, CAPA meetings, Complaint Meetings, and other meetings as required
o Follow-up on all action items from identified meetings
• Document Quality Assurance Reviews:
o Supplier change notifications (DCOs, ECOs, etc.)
o Testing protocols and reports
o SKU BOMs, product specifications, SOPs and Work Instructions
o Communicating revision needs to responsible parties
• Operations Backup
o Act as a backup to critical Ops dept functions during periods of absence, special functions, as required.
• Assist with other aspects of the Quality Management System as needed, including:
o Assisting with performing Internal and Supplier Audits
o Prepare and present information and data to Management, external auditors, and regulators as needed.
o Lead initiatives to develop and/or improve processes
o Special projects as identified
MINIMUM REQUIREMENTS AND QUALIFICATIONS
• Minimum of four (4) years of experience in a regulated environment/ FDA / ISO 9001 or 13485
• Experience in group and individual staff training.
• Strong computer skills and proficient with MS Office products; excel/power point/word
• Effective oral and written communication skills.
• Effective organization skills.
• Prior experience working with customer complaints and corrective action systems
• Prior experience with document control systems
• Unwavering Attention to detail and follow-through.
DESIRED SKILLS AND QUALIFICATIONS
• BS preferred
• Prior experience with employee training programs
• Strong data analysis and presentation skills
Interested candidates are invited to submit their resumes and cover letters to: email@example.com with salary requirements. Kindly include the position for which you are applying in the subject line. Due to the volume of resumes we receive, only qualified candidates will be contacted. No calls, please.
Thank you for your interest in OrthoAccel Technologies, Inc.