Senior Supplier Quality Engineer
Quanta Dialysis Technologies, United States
Job Description
Quanta Dialysis Technologies is a pioneering medical device company entering the US market from the UK. We are on a mission to become the world’s leading provider of self-care solutions for hemodialysis patients, and we are only at the beginning of our story.
We are poised for big things in 2022 and beyond, and this pivotal role will form part of our founding US team and help lay the building blocks for our future success. This is your chance to join a fast-growing company in a newly developed position, where you will have a unique opportunity to make an impact on the growth and development of the team.
The Senior Supplier Quality Engineer is responsible for maintaining the Supplier Quality Program for Quanta Dialysis Technology and support with all Supplier Quality compliance related activities, including but not limited to, Supplier audits, Supplier Selection, Supplier Management, Supplier Approval, supporting Regulatory audits, developing processes and procedures and making sure the organization is compliant with the ISO13485, MDSAP, MDR and other regulatory requirements.
Key Responsibilities
- Provide Supplier Quality support for sustaining and development projects.
- Plan, develop, implement, and maintain robust Supplier Quality program.
- Support the organization in developing and updating the Quality Management System (QMS) with supplier quality processes.
- Provide support and leadership in writing Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to supplier management program.
- Support Management review meetings by providing Supplier Quality data.
- Generate weekly and other routine reports for Key Process Indicators (KPI) discussion with the Management.
- Maintain supplier scorecards for the key suppliers.
- Chair periodic Supplier Review meetings with Senior Leadership.
- Support with change implementation at the supplier facilities.
- Process Corrective and Preventive Actions (CAPAs), Non-conformances (NCs), and Deviations associated with the suppliers.
- Support with Quarterly Business review meetings with the key suppliers.
- Experience with ISO13485, 21 CFR part 820, ISO9001, MDSAP amp; MDR requirements.
- Support External Regulatory Audits for supplier related activities.
- Manage Supplier Audit plans and execution of supplier audits for critical suppliers.
- Manage Supplier Quality Metrics.
- Support with Supplier Agreements and selection and approval of suppliers to add them to the Approved Supplier List.
- Facilitate the handling of supplier quality issues through execution of Supplier Corrective Action Request (SCAR) process.
- Accountable for making sure adequate investigation completion and robust corrective actions implementation by the suppliers.
- Support Supplier Remediation and Supplier Development activities as required.
- Support with Qualification activities at the supplier site.
- Develop Vamp;V plans and reports with the supplier for key processes.
- Develop AQL and Acceptance activities with the suppliers for key components or contract manufacturers.
- Support with supplier surveys, supplier questionnaires for onboarding and routine monitoring.
Requirements
- BS/BA in Engineering or Science preferred
- 5+ years of experience in medical device
- Intermediate knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, and applicable international quality standards including ISO 13485, MDR, Medical Device Directive, and ISO14791.
- Strong analytical skills, excellent verbal communication and customer interface skills.
- Ability to interface with multiple groups in the organization.
- ASQ certification is a plus.
- Data analysis skills preferred.