Value Chain Quality, Make QE Director - Medical Device
Johnson & Johnson is recruiting for a Medical Device Quality Engineer Director and can be located anywhere in the Globe, including remotely.
Johnson & Johnson Family of Companies, caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $74.3 billion in 2014 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.
You, the Value Chain QualityMake Leader will:
Embed Proactive Quality and apply the integrated Enterprise Make Quality Engineering strategy to improve reliability and drive strategic value in One MD
- Collaborate with J&J Make Quality Engineering Council
- Achieve business alignment and approval for strategic direction and investment
- Build and maintain relationships at all levels throughout the organization to deliver improved value (i.e.: reduced risk, complexity, cost)
- Collaborate with peers and business partners to ensure agile alignment with end-to-end processes and support current and future business
- Establish an integrated E2E One MD-based Make Quality Engineering strategy and transformation plan that links to the overall Enterprise QE strategy
- Build relationships between VCQ and Make Quality for OneMD
- Partner with Make Quality Operations groups to develop strategy and roadmap
- Gain membership to develop and deliver Make Quality transformation
- Link to MFF, JJOS & innovative healthcare solutions strategy
- Deploy global strategies for E2E QE that drive value across regions and segments
- Implement J&J Make Quality Engineering Strategy in One MD, leveraging E2E standards, innovation, processes, tools, and capabilities to drive maximum value
- Stay abreast of external trends and leading practices for potential J&J adoption
- Develop QE strategies for disruptive technologies
- Own and deliver the QE strategy and playbook in support of JJOS and MFF regarding quality processes, quality oversight, quality competences and batch release principles
- Own and deliver enterprise continuous improvement roadmap for Make QE in collaboration with One MD, making use of data analytics and QE tools to achieve value proposition
- Deliver proven practices to improve process & product quality per business priorities
- Advance the Value Chain Quality Vision
- Provide Subject Matter Expertise in QE practices and principles to enable and drive standardization where it provides value, reduces risk, improves capability, increases value and/or regulatory compliance
- Recommend new technologies to support E2E Design strategies and improve quality of services to the customer
- Bachelor's degree (or equivalent) in Engineering or relevant scientific/technical field or an advanced degree (for example, Master's, Ph.D.) in Engineering or relevant scientific/technical field and 8 or more years of relevant experience.
- Ability to shape a future vision, gain support and alignment to that vision, and drive strategic direction and deployment of goals and objectives into meaningful actions.
- Strong negotiation, communication, and change management skills
- Functional knowledge of/and experience in Quality Assurance in Medical Device, Pharmaceuticals or other healthcare regulated products is required
- A minimum of 10 years broad-based technical/engineering expertise / experience in any of the following R&D / Source / Manufacturing / Engineering / Quality / Delivery or equivalent
- A Minimum of 5 years of people management experience is required
- Experience working in the regulated health care industry is required
- Proven success in influencing highly successful teams is required
- Ability to manage global teams
- Ability to lead in matrix management environment and able to work collaboratively globally/cross-functionally as well as across segments/regions
- Managing risk, including escalation, prioritization and resolution of Quality issues
- Creating a direct and indirect organization that delivers results
- Showing initiative in innovative approaches to Quality challenges in a fast-paced, changing global environment
- Capable of building strong partnerships across segments & regions, acting as the mediator between organizations while optimizing the value proposition
- Building consensus and impacting outcome with limited authority and ability to negotiate trade off decisions across the organization
- Must have strong collaboration and influence management skills to partner effectively at all levels
- Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally
- Makes the customer central to all thinking
- Problem solving and Credo-based decision-making skills
- Communicating effectively at all levels of the business
- Ability to drive timely decisions with sometimes minimal data
- Quality management, supervisory and people development skills preferred
- Knowledge of fundamental quality engineering principles such as PE/Lean methodology and tools / Process
- Validation, Risk Management, and Process Control & Capability
- Capable of assuming technical hands-on leadership
- Ability to coach talent on Quality Engineering principles and practices
- Analytical skills and experience leading risk-based oversight programs
- Bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level and detailed, etc.
- PE Black Belt (or higher) certification preferred, though not required
- QE Certification preferred, though not required
- This position can be located anywhere in the Globe, including remotely and may require up to 30% domestic and international travel, depending on the location of the role
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Bridgewater
North America-United States, Asia Pacific, Latin America, North America, Europe/Middle East/Africa
Johnson & Johnson Services Inc. (6090)
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