Quality Engineer
Job Title: Quality Engineer
Company Overview:Stirling Q&R is a leading company in the medical device industry, dedicated to delivering innovative solutions that enhance patient care. We are currently seeking a passionate and detail-oriented Quality Engineer to ensure our products meet the highest quality standards and regulatory requirements.
Position Summary:As a Quality Engineer, you will be responsible for designing, implementing, and maintaining quality assurance processes throughout the product lifecycle. You will work closely with cross-functional teams to identify areas for improvement, ensure compliance with quality regulations, and contribute to the continuous improvement of our products and processes.
Key Responsibilities:
- Develop and implement quality assurance protocols and standards to ensure product compliance.
- Conduct risk assessments and failure mode effects analysis (FMEA) for new and existing products.
- Perform root cause analysis on product defects and nonconformities, driving corrective and preventive actions.
- Participate in product design reviews and ensure quality considerations are incorporated.
- Conduct internal audits and support external audits, ensuring compliance with ISO 13485 and other applicable standards.
- Develop and manage quality metrics to track product quality and process performance.
- Collaborate with manufacturing and engineering teams to optimize production processes for quality.
- Provide training and support to staff on quality-related topics.
- Document all quality activities and maintain accurate records.
Additional Information:
- Location: Based in the UK, with potential for hybrid work arrangements.
- Opportunity for professional development and growth within the company.
Requirements
Qualifications and Skills:
- Bachelor's degree in Engineering, Quality Assurance, or a related field.
- 2-4 years of experience in quality engineering within the medical device or related industry.
- Knowledge of quality management systems, ISO 13485, FDA regulations, and process validation.
- Experience with statistical process control (SPC), Six Sigma methodologies, and quality improvement tools.
- Strong analytical problem-solving skills and attention to detail.
- Excellent communication skills and ability to work collaboratively with cross-functional teams.
- Proficient in Microsoft Office Suite and quality management software.