OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Sr. Sustaining Quality Engineer responsible for providing expertise throughout the lifecycle of our Class I and Class II medical device product lines, with a primary focus on sustaining engineering. This role is responsible for ensuring high quality components are specified, manufactured and delivered by ensuring compliance with critical to quality requirements. Collaborating closely with R&D, Design Quality, and Operations, this role ensures effective hand-offs and communication in support of on-market products, new product development, and continual process improvement activities.
- Plan and execute quality-related maintenance and improvement activities related to purchased part qualification of supplier-produced materials, components, and devices as well as qualification of in-house materials to prevent or minimize quality issues. Develop and improve supplied parts inspection strategies based on establishment, implementation and improvement of related quality metrics and monitoring of critical to quality indicators. Participate in supplier selection, evaluation, qualification and requalification activities including equipment qualification and process validation (IQ, OQ, PQ), process capability (Cpk, Ppk), gage R&R, ISO 14971 risk management activities and process improvements.
- Manage Supplier Corrective Action Requests (SCARs) by leading and participating in teams to investigate, analyze, correct and drive corrective action for supplier related nonconformances. Communicate effectively with suppliers regarding SCARs and other quality issues. Evaluate impact of supplier change requests; lead cross-functional teams to identify and execute appropriate actions.
- Facilitate compliant and timely process deviation, change control and quality planning activities.
- Lead CAPA and NCMR investigations and support investigation teams relating to product functionality and design improvement.
- Understanding of and ability to interpret and apply ISO 13485, ISO 14971, and 21 CFR Part 820, specifically design controls, purchasing controls, risk management and production and process controls
- Proficiency leading CAPA investigations and supplier corrective actions
- Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint)
- Excellent written and verbal communication skills
- Results-oriented, positive “can-do” attitude with appropriate urgency and tenacious follow-up
- Ability to work as a collaborative team member as well as independently supervision
- Excellent attention to detail, producing high quality output appropriate to broader context
- Flexibility and strong organizational skills with ability to prioritize multiple tasks
- Strong interpersonal relationship skills including negotiating and relationship management
- Applies sound judgment when making decisions and communicating with peers and management
- ASQ Certified Quality Engineer (preferred)
- BS degree in engineering, science, technology, etc.
- 3+ years in medical device quality and/or operations
- Solid computer skills using Excel, Word, and Outlook
- Innovative products
- Awesome benefits
- Great coworkers
- An evolving, engaging culture and work place
It is an exciting time at OrthAlign - make your next career move with us!