Reference Number: JO-2307-519802
Manufacturing Quality Engineer
Job Type: Permanent
Location: Milton Keynes
Our client a leading Medical Device Manufacturer are looking to appoint a dedicated and technically proficient Manufacturing Quality Engineer to join their team and contribute to the manufacturing and production processes of our electronic medical devices.
The Manufacturing Quality Engineer will be responsible for ensuring smooth operations, troubleshooting production issues, conducting quality control checks, and providing technical support to the production and design team.
The ideal candidate has a strong background in engineering, particularly in the medical device industry, and possesses excellent problem-solving and communication skills.
ESSENTIAL DUTIES & RESPONSIBILITIES: Include but not limited to:
• Collaborate with the production team to ensure efficient manufacturing processes for electronic medical devices.
• Monitor and troubleshoot production equipment to identify and resolve any technical issues or malfunctions that may arise.
• Conduct regular Process control checks to ensure adherence to product specifications and regulatory standards.
• Provide technical guidance and support to production operators and technicians to optimize production efficiency and minimize downtime.
• Develop and maintain standard operating procedures (SOPs) for production processes, ensuring accuracy and compliance with quality standards.
• Identify areas for process improvement and propose solutions to enhance productivity, reduce waste, and improve overall product quality.
• Collaborate with cross-functional teams, including R&D, engineering, and quality assurance, to address product design and manufacturing issues.
• Participate in the validation and qualification of manufacturing equipment and processes.
• Ensure compliance with regulatory requirements and standards, such as FDA regulations and ISO certifications.
• Maintain accurate documentation and records related to production activities, troubleshooting, and process improvements.
KNOWLEDGE AND SKILLS TO BE SUCCESSFUL IN THE JOB
Education Required: Bachelor’s degree in engineering or a related field Education Preferred:
Bachelor’s degree in engineering or a related field Years of related experience:
5-7 years’ experience in in regulated environment, Quality systems, engineering or equivalent experience desirable. (Medical Device, automotive, aerospace. Electronics Med Device preferable)
• Proven experience in a production or manufacturing support role, preferably in the medical device industry.
• Solid understanding of electronic components, circuits, and assembly processes.
• Familiarity with medical device regulations, such as FDA QSR, ISO 13485, and IEC 60601.
• IPC (Association Connecting Electronics Industries) Standards: Familiarity with standards such as IPC-A-610 (Acceptability of Electronic Assemblies) and IPC-J-STD001 (Requirements for Soldered Electrical and Electronic Assemblies) ensures adherence to quality and workmanship criteria in electronic assembly processes.
• Familiar with Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
• Experience in interacting with regulatory agencies (FDA, MHRA, TUV, etc.) advantageous.
• Excellent communication skills, both written and verbal, to effectively collaborate with cross-functional teams, interact effectively at all levels and convey technical information.
• Detail-oriented with a focus on quality and adherence to regulatory requirements.
• Proficiency in using engineering software and tools for data analysis and process optimization.
• Knowledge of lean manufacturing principles, 5S and continuous improvement methodologies is a plus.
• Ability to adapt to changing priorities and handle multiple tasks simultaneously.
• Self-starter with ability to exhibit efficient work methods, analytical & problemsolving skills, provide effective solutions and to handle multiple tasks.
• Builds strong relationships by fostering open communications, respect and trust.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Strong verbal, written, and interpersonal skills