As the Quality Engineer your main area of responsibility will be supporting Quality Management activities for the development and transfer of Perimeter’s device design to a contract manufacturing facility. Day to day duties will include developing and maintaining Quality System procedures and documentation that are in compliance with ISO 13485, FDA, MDD, CMDR and cGMP requirements, and assisting other team members with Quality processes.
• Research, develop and revise Quality plans, procedures, work instructions for manufacturing, technical specifications, First Article Inspection and batch release testing requirements, in co-ordination with internal stakeholders and the contract manufacturer.
• Support design for manufacturing and design transfer efforts.
• Identify critical quality requirements, quality controls and critical process parameters, in the manufacturing process.
• Support the development of process capability studies, repeatability and reproducibility studies, as applicable, and establish metric-based process performance evaluation tools.
• Co-ordinate with the contract manufacturer to implement a cGMP compliant manufacturing process and subsequently support process verification and validation testing, as required.
• Support product verification and validation activities.
• Support processes for CAPAs, non-conforming material, product complaints, and field returns
• Participate in Risk Management activities and ensure compliance to standards and regulations (ISO 14971:2007 and ISO 14971:2012)
• Ensure DHR and DMR creation and maintenance in accordance with 21 CFR 820 and ISO 13485:2016 and 21 CFR Part 11 requirements.
• Evaluate and qualify selected suppliers and contract manufacturers
• Support the negotiation of contracts, including business agreements and supply agreements, with suppliers
• Participate in reviewing designs of new products and engineering changes with respect to product quality control/quality assurance and design requirements and recommend changes as required.
• Support all internal quality documentation and ensure appropriate storage of such documents for future reference and retrieval.
• Track any Supplier non-conformances and report to the QA Lead and Management. Work with cross-functional teams to find solutions to non-conformances.
• Maintain QMS documentation and records in accordance with ISO 13485:2016
• Support Quality System certification audit for MDSAP/ISO 13485:2016.
• Other tasks as assigned
• Minimum Three (3) years experience in a Manufacturing Quality or Quality Engineering role
• BS degree in Engineering or other related field
• Self-starter with ability to use own initiative to ensure company quality standards are maintained and the culture of continuous improvement is re-enforced
• Ability to manage multiple projects / assignments simultaneously
• Proficient in MS Office Suite- Word, Excel and PowerPoint
• Proven ability to collect the right data, analyze data using statistics, and implement improvements and corrective actions based on data
• Ability to analyze, challenge, and suggest changes to processes to improve efficiencies
• Honesty, integrity, and a strong desire to succeed
• Ability to establish high standards and interact with others in a respectful and professional manner
• Creative problem-solving skills
• Proven ability to recognize opportunities and to improve quality
• Able to work on very tight timelines while maintaining excellent attention to detail
• Experience working in a small team or start-up environment
Careers Perimeter Medical is currently seeking knowledgeable, creative and committed individuals to join our growing team. If you want to work with us to develop cutting edge surgical imaging tools, please send us your information. We offer a challenging and rewarding work environment.
Perimeter Medical is an equal opportunity employer and supports workforce diversity. Perimeter welcomes and encourages applications from people with disabilities. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.