QMS Engineer

job summary :

We are seeking a detail-oriented and proactive Quality Management Systems (QMS) Engineer to oversee and enhance our quality management systems.

The ideal candidate will have a deep understanding of quality assurance principles and the ability to implement and maintain QMS to meet industry standards and regulatory requirements.

Education and / or Experience :

• Bachelor's Degree in a science, engineering, or related discipline (Preferred : Chemical, Polymer, Biomedical, Materials Science, Industrial, Mechanical)
• 5+ years of progressively increasing responsibility in a medical device or related industry / organization
• Certified Quality Engineer and / or Certified Reliability Engineer, preferred
• Lean Six Sigma Green Belt or Black Belt, preferred
• Terminal sterilization of medical devices knowledge (EO / Gamma / I-Beam), including validation processes, preferred

Skills and Knowledge Requirements :

• Excellent working knowledge of 21 CFR 820, EU MDR, ISO 13485, and ISO 9001
• strong analytical, problem solving and technical writing skill
• The ability to work with a variety of disciplines and levels of staff both internally and externally
• Ability to work independently or as an integral part of a cross-functional team
• Able to understand, interpret, explain, and resolve technical issues
• strong project management and organizational skills
• Experience with statistical analysis and associated software

responsibilities :

QMS Development : Develop, implement, and maintain Quality Management Systems (QMS) in accordance with ISO standards and regulatory requirements to ensure consistent quality and compliance.

• Ensure implementation and rigor of product development processes and design control procedures are in compliance with the QMS.
• Provide support for post-market surveillance activities including but not limited to complaint investigations, Operations change control / risk assessments, document control, Quality Systems improvements, Regulatory & certification audit readiness, and internal audits,
• Problem-solving of technical issues related to design, development, and manufacturing supporting compliant, nonconformance, CAPA and SCAR investigations.
• Responsible for coordinating and managing project activities across all cross-functional team members to ensure timely completion of milestones.
• Serve as Audit Quality Administrator and subject matter expert during internal and external audits / inspections.
• Generate, review, approve, and / or execute changes and / or validations for Quality Systems to ensure compliance to US and International requirements for Quality Systems activities.
• Ensuring that the external manufacturers are qualified and monitored in compliance with the Supplier Quality Management program which may include validation / verification review, leading supplier quality audits, developing quality agreements, participating in monitoring activities, issuing SCARS, etc.
• Support complaint investigation activities within cross-functional teams and lead appropriate analysis of the information that supports continuous improvement in a timely manner.

Ensure corrective and preventative actions are effective.

• Lead and ensure compliance on Risk Management files which include Design FMEA & Process FMEA.
• Experience in interpreting US and international regulatory requirements and successful submissions for medical devices (510k's, CE mark technical files, etc.).
• In-depth knowledge of applicable global regulatory compliance requirements for personal protective equipment (PPE), drugs, cosmetics, and medical devices, including US FDA, NIOSH, Health Canada, TGA, and EUMDR.
• Knowledge and experience with ISO 13485 and ISO 9001 requirements is required.

LI-CB6

qualifications :

• Experience level : Experienced
• Minimum 5 years of experience
• Education : Bachelors

skills :

• Quality Systems
• Medical Device
• Regulatory Affairs / Compliance
• Compliance
• CAPA
• ISO 13485
• 21 CFR 820
• EU MDR
• Supply Chain
• ISO 9001
30+ days ago