The Supplier Quality Engineer is responsible to support Operational Quality activities in support of Product Development and Life Cycle processes including design controls, quality planning, risk assessments/analysis/management as relates to suppliers, design reviews, approval of test methods, and process validation test plans and reports. You will play an important role in reviewing and approving design changes and in developing/ improving risk-based product controls.
In the position you will be the contact person for all quality related issues for suppliers, including contract manufacturers. Additionally, you will closely work together with QA-colleagues, R&D, project leads and production. You will issue QA documents with sponsors, review the analytical methods/ results, production records, and qualification as well as validation protocols and reports and participate in other QA tasks as needed.
Essential Job Functions
- Direct management responsibility for Supplier Quality Engineering individual contributors
- Coordinate and lead execution of all Supplier management activities by conducting Supplier Quality audits to ISO 13485, issuing SCARs, and implementing design and/or process changes when needed.
- Implement and continuously improve global processes of the QMS related to Supplier Quality
- Reporting of Production Metric data and Supplier Management System outputs (SCARs, Supplier KPIs, Supplier Scorecard inputs, etc.) on regular cadence.
- SQE function oversight for Candela Product Quality interests to ensure production outputs and MFG Transfer projects are on-time and compliant
- Provide hands on support for resolution of Production impacting problems to ensure minimal impact to Candela business continuity
- Responsible for Review and Approval of supplier protocols and reports and Master Documents pertaining to Sustaining and/or qualification activities at suppliers, including Contract Manufacturing Organizations (CMOs).
- Responsible to provide Quality support and assign SQE resources at later stages of Product Development such as Process Development, Process Validation and Design Transfer.
- Responsible for the co-ordination with internal and external customer and R&D team to resolve Supply Base related product quality issues.
- Coordinate and support for release of Pilot builds and any applicable CMO activities
- Work with Engineering and QA colleagues to ensure necessary process controls are in place for design change implementation at suppliers and/or CMOs
- Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485 and other national and international quality and regulatory requirements and standards
- Develop statistically sound sampling plans and perform data analysis for process optimization
- Work with Lifecycle Engineering (LCE) Teams and other QEs to assure compliance to the QMS
- Analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles.
- Organization of functional strategy to ensure supply base is controlled, KPIs are visible/reported, and priorities are clear
- Additional projects as assigned
- Bachelor’s degree in Engineering or related field, 3-5+ years of related experience in the medical device or another regulated industry, preferably with management experience
- Expert understanding of appropriate global medical device regulations, requirements and standards, including Quality Management System (ISO 13485) and Medical Device Regulations (21 CFR 820) is a must
- ISO 13485 Lead Auditor Certification (Active) from accredited organization. Equally knowledgeable of MDSAP to be able to audit to it.
- Proficiency with Supplier Management tools/processes (SCARs, SREA, ASL management, Scorecard)
- Project Management (development of project plans, status meetings, project reporting, etc) and organizational change movement
- Ability to analyze information and come to conclusions based on presented data
- Ability to communicate effectively both orally and in writing
- Self-motivated and ability to manage time working on multiple projects simultaneously
- Demonstrated competency in computer skills: MS office applications, query tools, and enterprise database systems, ServiceMax and Agile is a plus
- Must be able to communicate appropriately and adequately to all management levels, including group presentation experience
- Fluency in Spanish is highly desirable
This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management.