Candela Corporation Manager, Supplier Quality Engineering in Marlborough, Massachusetts
Manager, Supplier Quality Engineering
Requisition Number 2089
Location US - Marlborough, MA
The Manager, Supplier Quality Engineering 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 andin developing/ improving risk-based product controls.In this 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
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
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.
Develop statistically sound sampling plans and perform data analysis for process optimization
Implement and continuously improve global processes of the QMS related to Supplier Quality
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.
SQE function oversight for Candela Product Quality interests to ensure Production outputs and MFG Transfer projects are on-time and compliant
Reporting of Production Metric data and Supplier Management System outputs (SCARs, Supplier KPIs, Supplier Scorecard inputs, etc.) on regular cadence.
Provide hands on support for resolution of Production impacting problems to ensure minimal impact to Candela business continuity
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, 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.
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
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.