OrthAlign

Supplier Quality Engineer

OrthAlign • $80K — $110K *
Irvine, CA 92620In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • BA/BS in Engineering or equivalent experience in medical device manufacturing supplier controls (2+ years) or 4+ years without degree.
  • Preferred: ASQ Certified Quality Engineer.
  • Preferred: Certified Auditor with auditing experience.
  • Strong knowledge of ISO 13485, ISO 14971, and 21 CFR Part 820 standards.
  • Proficient in leading CAPA investigations and supplier corrective actions.
  • Strong MS Office Suite skills for documentation and analysis.

Responsibilities

  • Execute quality maintenance and improvement activities for purchased part qualification.
  • Drive supplier development through quality audits and technical guidance.
  • Manage investigations of non-conforming materials and implement corrective actions.
  • Assist in validation processes for supplier outputs and maintain quality records.
  • Monitor and report on supplier-related quality metrics.

Benefits

  • Competitive compensation package including bonus and equity options.
  • Potential for career advancement within the company.
  • Comprehensive benefits package to support employee well-being.
  • Dynamic workplace culture focused on engagement and evolution.
Full Job Description
You will:
  • Execute quality-related maintenance and improvement activities related to purchased part qualification of supplier-produced materials, components, and devices to prevent or minimize quality issues.
  • Contribute to supplier development by driving execution of existing agreements, performing supplier quality audits, and provides technical advice and guidance to suppliers to reduce defect rates. Monitor supplier-related quality metrics.
  • Manage supplier related non-conforming material investigations, disposition, and manage supplier corrective actions to resolve product quality issues. Implements improvement plans for any supplier related complaints or process issues. Assist in supplier production validations. Maintain supplier quality records.


You need:
  • Your BA/BS Engineering-oriented degree and 2+ 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


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

About OrthAlign

OrthAlign is a medical device company that develops and markets surgical navigation systems for orthopedic surgery. The company's products include handheld devices that use computer algorithms to guide surgeons during joint replacement surgery. OrthAlign's technology is designed to improve the accuracy and precision of joint replacement surgery, reducing the risk of complications and improving patient outcomes. The company was founded in 2009 and is headquartered in Irvine, California.
Learn more about OrthAlign
Size
50 employees
Industry
Healthcare
Founded
2009
NASDAQ
* Ladders Estimates

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