Principal Quality Engineer

Company: New World Medical
Location: Rancho Cucamonga
Posted on: June 25, 2022

Job Description:

The Principal Quality Engineer will support new product development, product maintenance, and process improvements by fulfilling the design assurance role. The Principal Quality Engineer will handle projects and tasks, from product inception through product launch (new product development projects) and product maintenance (sustaining projects) and play an active role in the processes to ensure products meet quality standards consistent with the company's Quality Management System, while meeting all design control and appropriate regulatory requirements.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

• Works with R&D, Engineering, Manufacturing, Regulatory functions to define requirements for new product development. Partners with R&D to determine and define design inputs, design outputs, and design input/output relationships.
• Participate and lead new product development phase reviews and design reviews.
• Create and support the development and validation of new test methods.
• Evaluate the impact of any new product or changes to existing products on regulatory applications.
• Supports Sustaining Engineering for design and process changes to commercialized product.
• Ensure compliance of project activities to appropriate regulations and standards. A nonexclusive list of such regulations and standards would include ISO 13485, ISO 14971, 21 CFR part 820, CMDR and EU (MDD and MDR) regulations.
• Will fulfill the position of independent reviewer during the design review process.
• Assists with the selection and qualification of new and/or existing suppliers; this may include execution of Quality Management System supplier audits.
• Will be the liaison between the R&D team and manufacturing to ensure a smooth transition of the design. It is involved through all phases of Design Development and it is involved in the IQ, OQ, PQ, Design verification, Design Validation, supplier approval, and development.
• Use of statistical techniques for data analysis for deliverables such as design verifications and process validation.
• Other duties as assigned.
  KNOWLEDGE, SKILLS AND ABILITIES:
  • Excellent presentation, written and verbal communication skills, and interpersonal skills; ability to work in a team environment.
  • Strong understanding of design controls, risk management, and new product development processes.
  • Proficient in technical report writing and review.
  • Experience in statistical software packages (e.g. Minitab, Statistica, NCSS, etc.).
  • Proficiency in using Microsoft Office Applications required (MS Word, MS Excel, MS PowerPoint).
  • Project management and problem-solving skills are highly preferred.
    EDUCATION AND EXPERIENCE:
    • Bachelor's degree in an engineering or science field required; advanced degree preferred.
    • 7+ years of experience in medical devices.
    • Possession of relevant professional certifications related to quality systems and compliance for medical industry; ASQ and RAPS are preferred.
      PHYSICAL REQUIREMENTS:
      • Prolonged periods of sitting at a desk and working on a computer.
      • Must be able to lift 15 pounds at times.
        This description reflects management's assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.
        New World Medical, Inc. (NWM) is an Equal Opportunity Employer. NWM takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Keywords: New World Medical, Rancho Cucamonga , Principal Quality Engineer, Engineering , Rancho Cucamonga, California