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BackgroundOXOS Medical, Inc. is a dynamic medical technology company revolutionizing orthopedic imaging with its digital X-ray and multi-modal camera. Invented by an experienced orthopedic surgeon, the Micro C? is a groundbreaking medical imaging solution designed for surgeons that combines a compact, handheld X-ray source and a portable digital camera. OXOS Medical is expanding into cloud based imaging platforms, medical CAD, robotic guided imaging, intraoperative computed tomography and telemedical solutions for DoD and rural healthcare.What do we need?We are looking for a Technical Director of Quality Assurance to grow our quality team responsible for product quality assurance, quality engineering management and regulatory testing compliance activities. This position will coordinate quality engineering processes by directly interfacing with technical team leads. The position is hands on, leading a team of quality support staff and technical support personnel.What is involved?
Direct the refinement of the OXOS Medical Quality Systems and programs to ensure compliance with company policies and procedures, and industry regulations and standards, including FDA QSR, ISO 13485:2016 (medical device specific), CMDR, CFRs, and cGMPs, including 21 CFR Part 820, ISO 13485, ISO 9001 and ISO 14971 standards
Provide hands on quality implementation and grow the quality organization as needed based on company goals, progress, and budget
Provide Quality Systems technical expertise and/or support to facilities, suppliers, and other functional teams in large complex facilities or where highly regulated products are produced
Oversee Quality Assurance and Quality Engineer functions to work with other departments in the development of new products, processes and controls and to solve technical or quality related problems
Lead Quality Systems initiatives to ensure compliance to design control and risk management regulatory requirements
Lead automation initiatives to develop and extend the OXOS Medical technical management platform
Lead quality improvement efforts to further enhance quality systems, resolve top quality issues and mitigate compliance risk
Ensure compliance and inspection readiness of quality system and manufacturing facilities with applicable regulatory standards
Drive continuous improvements efforts for products and quality systems. Lead and coordinate the efforts within the entire operation to formulate and implement effective corrective and preventive actions to the internal and external assessments, adverse trends and quality issues
Establish goals and objectives for Quality department that are consistent with site?s Operations Objectives and Corporate Quality Objectives
What do we need from you?
4-7 years of Quality Engineering experience in an FDA-regulated industry (medical device, pharmaceutical, etc.) and working knowledge of 21 CFR Part 820, ISO 13485, ISO 9001 and ISO 14971 standards
In-depth knowledge of all QC/QA activities and regulatory requirements in the medical device industry, preferably medical electrical equipment
Experience in FDA inspections and strategy
Ability to use sound scientific judgment in management of the facility to prevent regulatory action
Understanding of cGMP?s and an ability to interpret and enforce regulatory requirements
Continuing education in the regulations, interpretation of the regulations, and revising internal practices and written procedures to comply with the regulatory requirements
In-depth knowledge of New Product Development (NPD) process and Design Control requirements (product risk analysis, design FMEAs, Use FMEAs, process FMEAs, design Verification and validation, test method development / qualification and statistical techniques)
Experience with compliance to IEC 60601
ASQ-Certified Quality Engineer (CQE) or Lean Six Sigma certification is a plus
Excellent communication skills, written and verbal
Ability to excel in an ever-changing, fast-paced environment
Background in engineering discipline preferred with deep familiarity with product design
What will you get?
The opportunity to work with an innovative, early stage company that is changing medical imaging as we know it
To work as part of an entrepreneurial team in our Midtown Atlanta office
Competitive pay, full benefits offering and equity in the company
Endless opportunities for growth and development
