Ensuring the highest quality standards in Ormco's products and processes by developing, implementing, and maintaining quality assurance protocols that comply with regulatory requirements and industry standards.
Requirements
- Strong computers skills demonstrating a firm knowledge of Microsoft Office software (Word, Excel, PowerPoint, Outlook, and Microsoft Project).
- Experience with statistical software (Minitab, JMP, etc.)
- FDA Quality System Regulation Part 820 and ISO 13485 experience highly desired
- Adaptable to work with software-based development and automated processes.
- Solves complex problems; takes a new perspective on existing solutions; exercises judgement based on the analysis of multiple sources of information.
- Ability to proactively influences designs to achieve product quality and reliability targets that meet or exceed customer expectations.
Responsibilities
- Performs quality engineering reviews of design documentation for compliance with stated requirements.
- Develops or participates in establishing requirements for all verification and validation (design and process) activities.
- Apply state-of-the-art inspection and quality engineering/assurance techniques, procedures, instruments, equipment, theories, principles and concepts to products and processes.
- Leads development of Risk Management documentation.
- Leads/participates in data collection, analysis, trending and reporting on non-conformances and investigations to determine root cause, corrective and preventive actions.
- Maintains process and software validation plans. Writes validation protocols. Facilitates completion of validation activities, performs data analysis, and writes the validation report.
- Applies statistical analysis of data to evaluate the current process and process changes.
Other
- Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
- Mentors junior Quality Engineers as required.
- Participates in internal and external audits and inspections.
- Prepares reports to communicate involvement and results of quality assurance and quality engineering activities.
- Prepares and presents technical and program information to team members and management.
