This role is with a Fortune Global 500 organization. There is an aggressive bonus structure to include a 20% peer equity as well as a 20% long term incentives (cash and stock options) bonus. The salary is negotiable but won't vary too greatly from the indicated base. They will also provide a full relocation package.
The customer is seeking a Director - Quality Assurance & Regulatory Affairs . The Director will report to the Vice President Operations. The Director’s quality role will focus on collaborating with many different disciplines including Engineering, Supply Chain and Field Service to track quality metrics, improve product quality and reliability, drive supplier performance and ensure organization-wide compliance with quality standards. In his/her regulatory capacity, the Director will ensure alignment of the company’s regulatory strategy to business strategy, provide regulatory insight (raising potential issues/concerns) on business matters, liaise with regulatory bodies, ensure regulatory compliance, and manage regulatory submissions.
The ideal candidate will possess strong electro-mechanical and regulatory knowledge, good analytical skills, excellent communication skills, a collaborative style, the ability to influence quality both within and outside the organization and a strong focus on the customer. He or she will lead the team which includes a Quality Analyst and Document Coordinator and potentially a Quality Engineer in the future.
Main Responsibilities:
Quality
Work with engineering to evaluate and develop design and process improvements for product reliability issues and to improve overall reliability and quality of products. Act as the primary liaison between field service, engineering and supply chain on reliability issues.
Own the Supplier Quality Management Program. Work with contract manufacturers and suppliers to improve quality through pre-qualification reviews, on-going oversight and audit, refinement of manufacturing processes, implementation of engineering changes and other procedures.
Working with the head of Field Service, perform audits of third party service providers to drive compliance with standards, contract and necessary performance expectations.
Assure engineering design processes and manufacturing processes are conducted in compliance with Corporate Quality Plan & ensure validation and testing protocols are robust. Instill an emphasis on designing & testing for reliability within manufacturing and development activities. Ensure FDA, ISO, UL, NSF and other regulatory requirements are met.
Generate reports, utilizing statistics, as appropriate, to evaluate trends and to aid management in the identification and resolution of issues and overall quality improvement effort. Recommend KPI’s to measure compliance with quality standards and effectiveness of corrective actions across all functions.
Assure control and proper disposition of nonconforming products and corrective actions.
Maintain Corrective & Preventive Action (CAPA) process and ensure timely follow-up, and implementation of corrective actions.
Conduct Internal Quality System Audits (including international audits) and assure corrective action is performed.
Maintain and update, as necessary, the Corporate Quality Plan, develop and deliver training to ensure organization understands and embraces quality procedures and verify on-going compliance with quality procedures.
Assure all team members are trained in the Quality System.
Manage complaint handling, medical device reporting, vigilance reporting, field actions, and label control.
Maintain fiscal responsibility and budget compliance.
Regulatory:
Act as the technical expert for all regulations (FDA, CE, UL, EPA, ISO, NSF, etc.) ensuring the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.
Monitor external regulatory developments, identify risks, and communicate potential issues to senior management.
Manage relationships within the relevant regulatory agencies to improve quality of submissions and understand the impact of any pending or proposed regulatory changes.
Assure all regulatory submissions are accurate and submitted in a timely manner. Determine if regulatory submissions are required or if a memo-to-file is adequate.
Educate/train company employees on regulatory matters to assure compliance with requirements.
Assure all marketing, sales and other materials (e.g. labels) and practices are in conformance with regulatory requirements.
Develop and maintain Material Safety Data Sheets (MSDS), as applicable.
Key Qualifications:
B.S. in Electrical Engineering or Mechanical Engineering strongly preferred. Equivalent work experience will be considered.
15 or more years experience in some combination of Engineering and Quality roles, some portion of which must include a manufacturing environment and medical devices, with at least 5 years in Quality function and at least 3 years with regulatory responsibilities.
Proven ability to create the Quality and regulatory strategies for an organization and experience lead others to achieve the related goals.
Extensive knowledge of: FDA (including GMP), CE, UL, EPA (specifically FIFRA), ISO, NSF strongly preferred.
Experience with electro-mechanical equipment, preferably to include some industrial/capital equipment and some medical devices experience. Controls experience strongly preferred.
A proven ability to deliver value in the following areas: supplier quality audits/improvement plans, reliability engineering, fault analysis and troubleshooting, corrective action tracking and quality management training.
Strong track record of collaborative working relationship with FDA and EPA which has led to successful outcomes for the business.
Experience with statistical analysis software preferred and ability to synthesize data from various sources to identify trends required.
Ability to manage and report on projects and drive them to conclusion.
Strong communication skills - able to challenge, influence, and articulate a view and drive behavior or action and train employees.
Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
Adaptability and resourcefulness to roll-up-sleeves and multi-task in order to thrive in small company environment.
-N/A- — possible extension and possible FTE opportunity.
