Sustaining Quality Engineer II

Job Description

Job Description

Salary : $110,000+ / year DOE

OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Sustaining Quality Engineer II to provide expertise of our commercially launched Class II medical device product lines with a primary focus on sustaining engineering. This role is responsible for ensuring the manufacture of high-quality medical devices by ensuring compliance with critical quality requirements, working closely with the Operations team to define process controls, process validation requirements, and in-process inspections. This role liaisons with Design Quality, Supplier Quality, and Operations to ensure effective hand-offs and communication in support of commercial products, new products, and continuous improvement activities. You will play an active role in facilitating nonconforming material report investigation and closure, failure investigations, CAPA actions, and change control activities.We enjoy being together working in our office, where we can collaborate and communicate more effectively and organically!

Note : This is not a remote position.

You will :

• Plan and execute quality-related maintenance and improvement activities related to devices as well as qualification of in-house materials to prevent or minimize quality issues.
• Develop and improve manufactured supplied parts inspection strategies based on establishment, implementation and improvement of related quality metrics and monitoring of critical to quality indicators.
• Collaborate with the Operations Engineers to determine the qualification and requalification activities for equipment qualification and process validation, process capability, test method validation and ISO 14971 risk management activities and process improvements.
• Lead CAPA and NCMR investigations and support investigation teams relating to product functionality and design improvement.
• Communicate effectively with internal counterparts regarding product related CAPA and other quality issues.
• Evaluate impact of proposed component, product and process change requests; lead cross-functional teams to identify and execute appropriate actions.
• Facilitate compliant and timely process deviation, change control and quality planning activities.
• Identify, propose and drive opportunities for improvement, including review and revision of procedures and associated documents. Support other quality system activities as directed by management.

You need :

We offer :

It is an exciting time atOrthAlign- make your next career move with us!

NOTE : We are unable to provide any type of sponsorship at this time.