Sr. Principal Quality Engineer Via Barrington James In Boulder CO

Company: Barrington James
About: Contract Life Science jobs
Position: Sr. Principal Quality Engineer
Duration: 12 Month Contract
Type: Part-Time (30 to 40 hours per week)
Location: Boulder CO (on-site 1 week, remote 3 weeks)
Client: Medical Device Manufacturer
Department: Quality
  • Effectively strategize and execute with all levels of the organization around concepts of design controls, process controls/validation;
  • Supplier controls, failure investigation and root cause analysis, inspection/test methods, sampling/statistical techniques, corrective and preventive actions, and risk management
Duties and Responsibilities:
  • Product Development:
    • Provide quality engineering strategic support to product development activities,
    • Including design verification and validation, test method development and validation, and general design control activities to assure submission-worthy objective evidence generation.
  • Notified Body primary contact for significant change notifications, certification maintenance, dossier review
  • Process Validation Monitoring:
    • Collaborate with Operations Team in process validation and monitoring strategy,
    • Including IQ/ OQ/ PQ, Test Method Validation, Gage R&R.
    • Author organizational Quality Plans.
    • Implement and monitor product and process quality using statistically based techniques.
  • Risk Management:
    • Lead product and process risk assessment activities:
    • FMEA and Risk Management Reports.
  • Supplier Quality:
    • Lead supplier qualification activities including conducting supplier audits.
    • Manage the Supplier Performance Program. Interface with suppliers to address non-conformances and drive timely corrective actions.
  • Audits and Inspections:
    • Lead preparation and inspection management activities.
    • Establish front & back room protocol, audit roles, etc.
    • Coach organization to a sustainable state of constant inspection readiness.
  • Customer Complaints:
    • Manage the customer complaint handling process,
    • Including performing failure investigations and root cause analysis.
    • Corrective and Preventive Actions:
    • Manage the CAPA program, including identification of quality issues/trends,
    • Perform or lead root cause analysis activities, identify, manage and/or lead corrective/preventive actions,
    • Oversee CAPA implementation and assess effectiveness.
  • Internal Audit:
    • Manage the internal audit program, including hosting internal audits,
    • Performing internal audits, and driving resolution of internal audit corrective action activities.
  • General:
    • Provide technical leadership, coaching and strategic guidance to the Quality team in the
    • Areas of inspection/test activities, calibration, cleanroom certification and monitoring, and sterilization validation.
    • Lead and manage quality system improvement projects and overall QMS suitability.
  • BS in Engineering, Science, Biomedical or related field of study. CQE certification preferred. ISO 13485 Lead Auditor certification strongly preferred
  • 12+ years of Quality leadership experience within the medical technology domain.
  • Experience in the manufacture of sterile disposable products a must.
  • Experience with intravascular devices a plus.
  • Combination product experience highly preferred
Knowledge, Skills & Abilities:
  • Knowledge and application of US and international standards:
    • Quality Management (FDA 21 CFR 820, ISO 13485)
    • Risk Management (ISO 14971)
    • Biocompatibility (ISO 10993-1)
    • Ethylene Oxide sterilization (ISO 11135)
    • Sterile Product Packaging (ISO 11607)
    • product Microbial Monitoring (ISO 11737)
    • Cleanroom Monitoring (ISO 14644).
  • Experience with building and conducting QMS Management Review
  • Direct experience with notified body and health authority interactions
  • Experience with medical device complaint handling/investigation and related post-market health authority inquiries
  • Experience with eQMS migration/implementation/validation
  • Knowledge and application of statistical techniques, SPC, DOE, and problem-solving tools.
  • Strong influence leadership and cross-functional, consensus building experience
  • Adept in use of computer software for the analysis of data, such as Microsoft Excel and Minitab.
  • Must possess a strong sense of urgency, teamwork, keen attention to detail, ability to plan, organize and multi-task.
  • Excellent communication skills (oral and written).
For more information and to apply
Contact: Conner Harman
Phone: +1 646 415 8221

Regulatory Affairs/QA and CMC - Contract
Senior Recruitment Consultant | Barrington James

News Boulder Section 08/03/2022 7:28am CDT


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