Director, Design and Supplier Quality bei Candela Corporation

Company Overview:

Candela Corporation is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint.  We are the market leader in the development, and distribution of medical and aesthetic laser and light-based technologies.  The Company’s technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic application including hair removal, wrinkle reduction, tattoo removal, improving the skin’s appearance through the treatment of benign vascular and pigmented lesions, and the treatment of acne, leg veins and other common indications.

The Company is headquartered in Marlborough, Massachusetts, USA, with an additional R&D facility in Yokneam, Israel and commercial locations across Asia Pacific, and Europe.  Products are sold directly in 18 countries worldwide and are supported by capital sales, field service, clinical education, technical support and marketing development organizations.  Candela maintains contracted distributors in over 60 other countries.

General Summary

The Director, Design and Supplier Quality is responsible for NPI Design Controls, Design Transfer, and the successful validation/maintenance/improvements linked to both CMO production and other supplied material. In this position you will have direct accountability for DQA, SQA, Test Method Validation (TMV), Computer System/Software (non-product) Validation (CSV), Periodic/Ad-hoc risk reviews, Sterilization, Labeling, and Design Transfer.  You also play a significant role in the cross functional development and implementation of digital transformation solutions across QA/RA and even other functions if the need is observed/justified.  All testing and controls should be risk based and aligned with a general zero-defect philosophy.

Essential Job Functions

·       Leads through Candela Values and reinforces a Quality Candela Culture across the company.

·       Analyzes market and industry trends to identify emerging customer needs and opportunities.

·       Effectively establishes and communicates a zero defects vision and aligns others around the required strategy, objectives, and plans.

·       Encourages/demonstrates responsible risk taking to achieve results; Understands the end-to-end impact on cross functional teams and deliverables to optimize solutions.

·       Builds (establishes) a culture of action and accountability for on-time deliverables.

·       Sets SMART goals, provides regular feedback on performance, and mentors others for career progression and success.

·       Anticipates obstacles and creates risk based contingency plans to achieve AOP/LT strategy in a changing environment.

·       Shows active and visible commitment to efficiency programs and continuous improvement initiatives.

·       Identifies and incorporates external and internal best practices into business processes.

·       Collaborates across functions to build internal support, create synergies, and achieve operating goals.

·       Preserves personal relationships even in heated or difficult/dynamic circumstances.

·       Global accountability for Design/Supplier Quality performance, Sterilization/Labeling compliance, and the successful completion of Design Transfer activities. 

·       Global accountability for assimilation, assessment, and potential improvement actions related feedback.

·       Jointly accountable with Quality System (QS) and Regulatory Affairs (RA) Leadership for ensuring the QS is effectively established/maintained according to company policies/procedures and applicable local/state/federal/international requirements.

·       Actively support Quality and Sustaining Engineering processes and the completion of project assignments.

·       Active involvement in the preparation and leadership of Management Review processes/meetings.

·       Support the successful integration of acquisitions into the global QMS.

·       Work cross functionally to establish processes that take advantage of AI/Machine Learning to minimize manual process steps and dramatically accelerate product quality data analysis, trend detection, and meaningful correlations invisible to current analysis methods

·       Leads with a hands-on style to assist in driving details as required to meet/exceed required deliverable performance/timing.

·       Lead and support Corrective and Preventive Action (CAPA) activities as required end to end for Candela.

·       Maintain expertise to develop statistically sound sampling plans, perform advanced data analysis, and use both basic and advanced statistical tools to solve problems.

·       Develop team to ensure capability growth with company/department strategies for growth/success.

·       Capable of establishing required supplier process control methodologies aligned with a Vision of Zero Defects (i.e. FMEA’s, Control Plans, Verification/Validation, Risk Engineering, and Statistical Techniques).

·       Establish processes for supplier classification and determination of requisite controls based on risk.

·       Collaborate with Procurement to establish supplier performance metrics and use the data to both recommend and implement supplier corrective actions/improvements.

·       Work closely with Field Service to understand customer issues and to identify process or product changes that will result in enhanced customer satisfaction.

·       Accomplishes staff results by communicating job expectations; monitoring and providing team feedback and coaching.

·       Other duties as assigned.

Knowledge/Educational Requirements

·       Bachelor’s Degree in engineering or related field, plus 12 years of related experience in the medical device industry with at least 10 years in a management/leadership role in quality / regulatory / compliance.

·       Expert understanding of relevant global/regional medical device regulations and standards with particular emphasis on MDSAP, MDR, and APAC regions.

·       Development and successful execution of project plans, status meetings, reporting, and closure.

·       Thrives in a Dynamic and Changing Environment.

·       Proficient in process development methodologies (FMEA, Validation, Control Plans, etc.)

·       Demonstrated ability to organize team thinking and drive root cause analysis to address failures; experience in capital equipment with mechanical and electrical manufacturing a plus.

·       Demonstrated ability to collaborate effectively with and lead cross functional teams

·       High level Project Management (development of project plans, status meetings, project reporting, etc.) expertise a plus

·       Accustomed to high-performance environment demands a self-motivating leadership/management style.

·       Knowledge of AI/machine learning techniques to accelerate performance a plus.

·       Ability to analyze information, develop a hypothesis and come to conclusions based on available data / trends.

·       Ability to communicate effectively both orally and in writing including to cross-functional partners, senior management, customers, and regulators.

·       Strong leadership capabilities with a track record of developing talent and leading team through times of ambiguity.

·       Demonstrated competency in computer skills: MS office applications, query tools, enterprise database systems, ServiceMax, and Oracle a plus.

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.