Opportunity: POSITION SUMMARY:
The Program Director for Product Proactive Quality is responsible for leading the Global Product Proactive Quality initiative. This purpose of this project is to identify product and process risks; to outline improvement opportunities to mitigate identified risks; create a structure to maintain design decisions and learnings for future use.
This position will provide leadership and program management support for the Product Proactive Quality initiative. The candidate will perform duties to ensure project requirements are established and completed within a defined timeframe determined by internal customers such as Operations, R&D, and QARA. This individual must be a team player and have a working knowledge of medical device regulations, design control, manufacturing operations, and design transfers.
This position will manage the Product Proactive Quality team. Division Information: The Corporate division is the central operating unit of the company setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. Company headquarters are located just outside of Philadelphia in Wayne, PA. Position Description: PRINCIPAL RESPONSIBILITIES:
•Implement and manage the Global Product ProActive Quality Program.
•Manage and coordinate various workstreams within the Product Proactive Quality program, involving projects across multiple geographies/regions.
•Drive the development of prioritized evaluation, planning and implementation approaches for products/projects that may be candidates for the product proactive quality initiative.
•Review and challenge where necessary the associated project plans from a technical quality and risk management point of view.
•Devise milestones for the product proactive quality process; create a review process to assess the outcomes of the product proactive quality analysis.
•Co-ordinate the actions to address the outcomes of the quality analysis for the project, working as an independent team and in collaboration with R&D, Operations, Quality, Strategic Initiatives.
•Provide recommendation action plans for improved Teleflex solutions to common challenges.
•Develop and co-ordinate scorecard/metrics for measurement of the program.
•Lead communication of the program to Product Proactive Governance team and Senior Management. Requirements: EDUCATION / EXPERIENCE REQUIREMENTS:
•Project Management expertise, 10+ years in Project/Program Management, PMP Certification an advantage
•Degree level life sciences, engineering or scientific qualification, Masters an advantage
•Knowledge of International Quality and Regulatory requirements and regulations including but not limited to FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485 Quality System requirements, Council Directive 93/42/EEC (Medical Device Directive), MEDDEV, Canadian Medical Device Regulations, Japanese JPAL requirements
•Management experience leading teams
SPECIALIZED SKILLS & OTHER REQUIREMENTS:
•Project Management excellence and proven track record with planning and execution
•Approachable and enthusiastic. Flexible and adaptable. Able to work on own initiative and as a team player.
•Good organizational skills with cultural awareness and sensitivity. Excellent interpersonal skills and ability to work with people from different cultural backgrounds to achieve results.
•Ability to work in cross-functional teams and with matrixed organizations.
•Ability to influence across functions and geographies.
•Demonstrates leadership and management of teams.
Opportunity: POSITION SUMMARY: