Junior Quality Engineer - medical device

ZipRecruiter; Manchester; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading company in the medical device R&D sector is seeking a Junior Quality Engineer to provide design quality support. This role involves compliance with quality regulations, participation in risk management activities, and improvements through Six Sigma. The ideal candidate will have a degree in engineering and relevant experience in quality control.

Qualifications

• 1+ years of experience in quality control of medical devices or related fields.
• Completion of Capstone, Co-Op, or project in the medical device field.
• Experience with compliance standards like 21 CFR 820 and ISO 13485:2016.

Responsibilities

• Work cooperatively with team members and compliance with applicable standards.
• Participate in Risk Management activities in accordance with ISO 14971:2019.
• Support system and process improvements using Six Sigma tools.

Skills

Attention to detail

Communication skills

Critical thinking

Problem-solving

Education

Bachelor’s degree in Biomedical, Mechanical, Electrical, or related engineering

Job description

InnoTECH Staffing is seeking a Junior Quality Engineer to provide design quality support in a dynamic, fast-paced environment of medical device R&D and manufacturing for a company in Southern, NH.

This is onsite 5 days a week. There is no sponsorship.

How you will make an impact as a Junior Quality Engineer:

• Work cooperatively with other team members and in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016
  • Evaluate project and design compliance to applicable standards and regulations
• Use critical thinking and analysis to determine the best approach and provide guidance on QMS compliance to design team members
• Support development of complex electromechanical devices including software through quality system processes
• Participate in Risk Management activities in accordance with ISO 14971:2019 such as FMEAs and Risk Analysis
• Assist in the development, implementation, and approval of Device Master Records and Device History Records
• Participate in investigations resulting in root cause and corrective actions through data analysis, inductive and deductive reasoning, and problem-solving skills
  • Coordinate the efforts of individuals and teams performing investigations
• Ensure the accurate documentation and recording of information for communication with partners and regulatory bodies
• Support system and process improvements using Six Sigma tools
• Support reliability and statistical analysis
• Assist in internal and external audits

Minimum Requirements:

• Bachelor’s degree in Biomedical, Mechanical, Electrical, or related engineering discipline
• Ability to work as part of a multidisciplinary team
• Excellent verbal and written communication skills, with attention to detail
• Ability to understand and provide guidance on quality system procedures
• 1+ years of experience in quality control of medical devices or related fields
• Completion of Capstone, Co-Op, or project in the medical device field
• Experience with medical devices, Risk Analysis, and Design Transfer
• Experience with compliance to standards like 21 CFR 820 and ISO 13485:2016