Quality Engineer

OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a 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:

• Your BA/BS Engineering-oriented degree and 2+ years of experience in medical device manufacturing
  
• ASQ Certified Quality Engineer, preferred
• 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
• Working knowledge of statistical techniques
• Ability to read and interpret drawings
• Experience with contract manufacturing and process validations.
• Proficiency leading and conducting Root Cause Analysis
• Strong interpersonal relationship skills including negotiating and relationship management
• Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint)
• Excellent written and verbal communication skills
• Ability to work as a collaborative team member as well as independently
• Excellent attention to detail, producing high quality output
• Results-oriented with appropriate urgency and tenacious follow-up
• Flexibility and strong organizational skills with ability to prioritize multiple tasks
• Sound judgment when making decisions and communicating with internal and external customers
  

We offer:

• Competitive compensation including bonus and equity
  
• Opportunities for career advancement
• Full benefits package including 401(k) and voluntary benefit offerings
  
• An evolving, engaging culture and workplace
• Nominated by our employees as a Top Place to Work in Orange County!

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

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