Sr. Principal Quality Engineer Via Barrington James In Boulder CO
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
- 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
- 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.
- 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 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).
Contact: Conner Harman
Phone: +1 646 415 8221
Regulatory Affairs/QA and CMC - Contract
Senior Recruitment Consultant | Barrington James