Company: Barrington James https://barringtonjames.com/
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
Summary:

• 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.

Qualifications:

• 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
email: charman@barringtonjames.com
Phone: +1 646 415 8221

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

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