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Senior Director, Plant Quality Assurance- Cornelia
Requisition ID: 7629180330
Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Plant Quality Assurance. This role will be based in Cornelia, GA.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
You, the Director, Plant Quality Assurance will:
- Lead the quality activities at the site ensuring the appropriate staffing is available at all times and skills and competencies are consistent with present and future needs, verifying that Quality Systems are in place to maintain the required compliance level across the manufacturing site, and driving Quality System execution while reducing risk of non-conforming product.
- Ensures site assesses QS effectively through internal audit and Management Review, and implements corrective/ preventive, improvement actions as appropriate. Ensures site addresses customer feedback and complaints in appropriate and timely manner. Ensures that site’ implementation of Quality Systems and goals are integrated in a cost effective and productive manner.
- Establishes and maintains QS procedures and controls ensuring that performance and quality of the product conforms to established company and regulatory standards.
- Establishes and monitors metrics for the measurement of Quality indicators and Quality costs to ensure effectiveness and value to the business. Developing & implementing annual budgets & organization plans.
- Ensures site fulfills all Quality Agreement requirements. Leads the plant staff in the understanding, development and deployment of key strategies, continuous improvement opportunities and customer focus initiatives.
- Leads the identification and analysis of risks, and leads the implementation of preventive and corrective actions to address risks.
- Potential Develops and disseminates strategy for talent attraction, development and retention to enhance the Quality Operation’s talent pipeline. Ensures manufacturing site has appropriate resources with the right competencies to execute the Quality System.
- Provides active link and partnership between the sister sites, franchise partners, regions and enterprise functions. Partners with management to develop and support initiatives and responses to internal issues. Fosters resource leverage across sites and regions, ensures alignment or harmonization where required and/or appropriate.
- Executes responses to field actions and coordinates global response in partnership with the franchise Quality leadership and enterprise functions. Oversee release systems of all products manufactured at site.
- Oversee & direct participation in quality systems improvement, cost reduction, cycle time reduction, & profit improvement programs. Collaborate with all business representatives to further corporate goals, values & objectives. Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).
DRIVING A TURNAROUND TO BRING SITE QUALITY PERFORMANCE UP TO STANDARD
- Develop and implement a holistic multi-year strategy across culture, people, processes and systems.
- Insert high level areas of focus based on site performance (i.e. compliance, financials, safety etc.)
- Balancing challenges in the short/mid-term with a focus on the long-term potential
- Challenge the status quo to implement new ways of doing things that are proven practices outside the organization
- Strong performance with positive impact when interacting with regulatory bodies
LEADING THE IMPLEMENTATION OF A PROACTIVE QUALITY CULTURE SITE-WIDE
- Build credibility to influence trade-offs with Supply Chain that provide end-to-end value and ensure the protection of patient safety.
- Instill quality mind-set site-wide through capability building within and outside of Quality function
- Making tough talent decisions
- Demonstrating fortitude to stand in front of Supply Chain management regarding possible Quality calls
- Taking a stand for tough calls; being the lone voice in the room
- Working with difficult or strong personalities
- Working through multiple set-backs and unforeseen challenges without losing ‘winning spirit’
- Consistent ‘beacon of hope’ for Quality organization
INSPIRE AND MOTIVATE
- Ability to paint a vision of the future that is relatable to all levels of the Quality organization and site-wide
- Inspire intellectual curiosity in the Quality organization to collaborate outside of Cornelia and bring best practices into the organization from other segments
- BS in Business, Life Science, Physical Science or Engineering required, Master’s Degree preferred.
- Minimum of 10 years of combined experience in Regulatory, Compliance, Quality Management and/or Supply Chain in a regulated environment. Minimum of 5 years people leadership experience is required.
- Experience driving high performing cross-functional and indirect teams that deliver results is required. Experience leading a turnaround preferred
- Experience outside of the Medical Devices segment an asset
- Strong experience and proven record motivating leading and developing staff, in a highly changing environment is required.
- Six Sigma, Quality Engineer, Quality Auditor and/or Quality Manager Certifications are preferred.
- Strong followership through demonstration of passion and inclusiveness
- Driving and being a promoter of transformation
- Know your #’s and how they impact the bigger picture from a total site perspective
- General manager mindset to have an equal seat at the table with Supply Chain
- Influencing and negotiating across the organization; effective negotiator
- Dealing effectively with resistance
- Ability to make tough data/fact-based decisions quickly
- Strong collaboration skills
- Stand firm, intestinal fortitude; having a voice in the room
- Resilient and persistent
- Coaching leadership style that develops talent
- Enjoys a tremendous challenge
- Enjoys complexity of driving change and making a difference
- Creating a legacy
- "Entrepreneur” spirit; enjoys bringing new ways of doing things to the table and collaborating to implement those new practices
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
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.
Ethicon Inc. (6045)