Quality Engineer

The Quality Engineer will play a critical role in ensuring the quality and compliance of our medical devices throughout the product lifecycle. This position involves implementing and maintaining quality management systems, managing non-conformances, and driving continuous improvement initiatives. The ideal candidate will have a strong understanding of medical device regulations and a passion for ensuring product safety and efficacy. This is a full-time, on-site position.

Product Quality:

• Support product development and design verification/validation activities.
• Develop and implement quality control plans for manufacturing processes.
• Analyze quality data and identify trends to drive continuous improvement.

Validation and

Qualification:

• Support test method, process, cleanroom, and equipment validations (IQ/OQ/PQ).
• Create and maintain validation documentation
• Establish and monitor triggers for re-validation and periodic review of validated processes and equipment to ensure they remain in a qualified state.

Quality Management System (QMS):

• Support development, implementation, and maintenance of the company's QMS to ensure compliance with ISO 13485, 21 CFR Part 820, and other applicable regulations.
• Ensure QMS documentation is accurate, up-to-date, and effectively implemented.

Auditing and Compliance:

• Assist the QA Department in conducting internal and external audits to assess compliance with regulatory requirements and company procedures.
• Support regulatory submissions and inspections.

Non-Conformance and CAPA:

• Assist the CAPA Process Owner investigating and resolving non-conformances.
• Assist the CAPA Process Owner, ensuring thorough root cause analysis and effective corrective actions.
• Conduct risk assessments and develop risk management plans in accordance with ISO 14971.
• Ensure risk management activities are integrated into product development and manufacturing processes.

Safety, Organization, and Productivity:

• Know, understand and adhere to all safety standards, i.e., emergency preparedness, chemical, infectious agents and radioactive hazards.
• Participate in the introduction and evaluation of new procedures, supplies and equipment.
• Ensure proper training of colleagues, etc.
• Use resources (equipment, disposables, time) in a responsible, cost-effective manner.

• Education:
  • Bachelor’s degree in engineering, science, or a related field.

• Experience:
  • Minimum 3 years of experience in quality engineering within the medical device industry.
  • Strong knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and other applicable medical device regulations.
  • Experience with auditing, CAPA, risk management, and validation.
  • Proficient in using quality management software and tools.
  • ASQ Certified Quality Engineer (CQE) is highly desirable.
  • Experience with statistical process control (SPC).
  • Experience with design control.
  • Working knowledge of MRP or MES systems, preferably in Microsoft Dynamics 365.

• Skills:
  • Strong analytical and problem-solving skills and effective application of Data and Statistical Analysis Techniques.
  • Effective Communication and Presentation Skills.
  • People-focused Leadership, Coaching/Developing others, and strong Team Orientation.
  • Willingness to mentor other team members and share knowledge
  • Demonstrated Ethics and Integrity, Resourcefulness, and Flexibility.
  • Results Focus / Output Orientation and Decision-Making capability.
  • Ability to work independently and efficient Project/Task/Time Management.
  • Proven experience in validation and qualification
  • Must be able to work well independently, as well as being able to work cooperatively in a team of professionals.
  • Proficiency in ERP, especially Microsoft Dynamics 365, is a plus.
  • Technical Writing

Ability to travel domestic and international

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Mobility & Posture
  :
  May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.
• Li…