Principal Quality Engineer

Cardinal Health-posted 3 months ago
$80,900 - $121,275/Yr
Full-time • Mid Level
Hybrid • Mansfield, MA
5,001-10,000 employees
Merchant Wholesalers, Nondurable Goods
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Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Engineering manages product and service quality planning, evaluation, and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services. This is a hybrid (3+day in the office) position. The candidate needs to be in either Hazelwood, MO or Mansfield, MA.

  • Responsible for participating in product design and development.
  • Conduct data and risk assessments for various product lines.
  • Apply FDA QMS/QSR to provide regulatory support (strategy) for new product development, change assessments, design verification and validation, design control.
  • Revise SOP documentation and create and approve change orders.
  • Work cross-functionally with engineering, regulatory and design to introduce new line extensions and new products as well as day-to-day operations to support manufacturing and continuous process improvements.
  • Provide oversight and participate in CAPAs, NCR, complaints and audits.
  • Bachelor's degree in engineering or relevant work experience, preferred.
  • 4-8 Years of experience in related field, preferred.
  • Understanding of federal, state, local and industry standards, guidelines, and regulations (i.e., AAMI, ANSI, GMP,21CFR820, 14971 and ISO 13485), preferred.
  • Excellent attention to details and organizational skills.
  • Excellent interpersonal skills and ability to collaborate cross-functionally with Engineering, Manufacturing, Supplier Quality, Compliance, Packaging, Labeling, Marketing, etc.
  • Strong analytical, problem-solving, and technical writing skills.
  • Proficient with Microsoft office, Minitab or related software and applications, preferred.
  • Knowledge of Internal and External Audit Activities, preferred.
  • Knowledge and confidence lead to the identification, investigation, and resolution of quality issues by conducting thorough root cause analysis and implementing effective Corrective and Preventive actions (CAPA), preferred.
  • Knowledge in supplier quality management, contract manufacturing processes and private brand development to ensure product excellence and strategic alignment, preferred.
  • ASQ, BSI, IRCA or related Certifications are a preferred.
  • Medical, dental and vision coverage
  • Paid time off plan
  • Health savings account (HSA)
  • 401k savings plan
  • Access to wages before pay day with myFlexPay
  • Flexible spending accounts (FSAs)
  • Short- and long-term disability coverage
  • Work-Life resources
  • Paid parental leave
  • Healthy lifestyle programs
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