Associate Manager, Quality Engineering

OrthAlign, Inc.; Irvine (CA); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Competitive compensation including a 0

Bonus and equity

Full benefits package

Career advancement opportunities

Top Place to Work in Orange County

Job summary

OrthAlign, Inc. in Irvine, California is seeking an Associate Manager, Quality Engineering to lead supplier quality programs for manufacturing, packaging, and related operations, ensuring compliance with ISO 13485 and regulatory requirements.

You will partner with design engineering and cross-functional teams to qualify suppliers, manage CAPA investigations, drive process transfers, and ensure readiness for full-scale production at contract manufacturers.

Qualifications

• BA/BS engineering degree with 5+ years in medical device supplier controls, or 4+ years in supplier controls.
• ASQ Certified Quality Engineer preferred.
• Auditing experience required, preferably supplier audits.
• Understanding of ISO 13485, ISO 14971, and 21 CFR Part 820 (design/purchasing controls, risk).
• Proficient leading CAPA investigations and supplier corrective actions.

Responsibilities

• Serve as the quality point of contact for parts, services and contract manufacturers.
• Lead supplier and CM qualification, onboarding with Manufacturing Eng and Supply Chain.
• Monitor supplier/CM performance via evaluations and audits.
• Collaborate with Design Quality Engineers on DFM/DFA and inspection requirements.
• Support development, validation (IQ/OQ/PQ), and transfer of processes and methods.
• Ensure readiness for full-scale production launches at CM.
• Lead quality ops for internal manufacturing processes.
• Create and maintain manufacturing documentation (MPs, Routers, MVPs, PFMEAs, BOMs, procedures).
• Lead CAPA investigations; support audits of QMS; drive improvements.
• Hire and develop direct reports; provide coaching and training opportunities.

Skills

Quality systems

CAPA investigations

Auditing

Supplier management

Communication

Team leadership

MS Office

Education

BA/BS Engineering-oriented degree

ASQ Certified Quality Engineer

Tools

MS Office Suite

Job description

OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for aAssociate Manager, Quality Engineering is responsible for managing supplier programs for manufacturing, packaging, and other operational processes, as well as ensuring that quality programs are in compliance with regulatory requirements. This role supports the OrthAlign mission by reporting and acting on trends in supplied material and component quality requirements. This position works closely with the design engineering and cross-functional teams to ensure that suppliers are capable of meeting the OrthAlign product quality requirements.

NOTE: Local Candidates Will Be Considered.

You must have the ability to report daily to our headquarters in Irvine, California.

You will:

• Serve as the quality point of contact for parts and service suppliers and Contract Manufacturers (CMs) involved in the production of devices.
• Support supplier and CM selection and lead the qualification, and onboarding processes in collaboration with Manufacturing engineering and Supply Chain.
• Lead/manage ongoing monitoring of supplier and CM performance through the completion of supplier evaluations and conducting supplier audits.
• Collaborate closely with Design Quality Engineers prior to Design Transfer completion to support Design for Manufacturability (DFM), Design for Assembly (DFA), and developing inspection requirements.
• Support the development, validation (IQ/OQ/PQ), and transfer of manufacturing processes, equipment, and test methods to manufacturing.
• Ensure successful manufacturing readiness for full-scale production launches at CM.
  
• Lead/manage quality operations related to internal manufacturing processes.
• Support the creation and maintenance of manufacturing documentation & deliverable (MPs, Routers, MVPs, PFMEAs, BOMs, Inspection Procedures, etc.)
• Lead supplier, manufacturing or product related CAPA investigations and support CAPA investigation teams relating to product functionality and design improvement. Support audits of the quality management system, specifically relating to Design Transfer, process and test validation, and related processes. 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.
• Hire, oversee, develop, and guide direct report(s) to ensure tasks are completed effectively and efficiently. Provide constructive criticism and praise to help employees improve and stay motivated. Identify training needs and facilitate opportunities for skill enhancement.

You need:

• Your BA/BS Engineering-oriented degree and 5+ years of experience in the medical device manufacturing supplier controls, or 4+ years of experience in the medical device manufacturing supplier controls
  
• ASQ Certified Quality Engineer, preferred
• Certified Auditor, preferred
• Auditing experience is required, preferably in the area of supplier audits
• 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 action
• 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
  
• An evolving, engaging culture and workplace
• Nominated by our employees as a Top Place to Work in Orange County!

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

This position reports to our Irvine office daily.

NOTE: We are unable to provide any