Through partnership with Supply Chain (Ops, Value stream), R&D, QA, and commercial leadership, this position leads the monitoring, analysis and improvement of all aspects of brand quality from NPI through to the customer as well as the communication back to commercial on the brand health, to improve brand equity. In parallel to the field performance, work with regulatory and quality systems both at an operating company level and an enterprise level, to look at the health authorities' compliance landscape and incorporate proactively in the improvement strategy.

As a result, the position leads the strategic 10-year overview quality plan per brand addressing patient needs, using a combination of new product and improvement approaches.

Key Responsibilities:

To act on the strategy, the position holds key quality decisions on the brands.

• Partner with commercial organization, regional offices, Regulatory and Complaint handling to gather all short and long term information on the brands as they relate to performance in the field
• For new products, partner with R&D leadership to modify the new product development to optimize product quality. Position has the accountability assess these launches as they relate to Product quality and has the scope to accelerate, modify or delay new product launches
• For existing products, partner with Supply Chain Leadership to assess and implement modifications to the manufacturing processes and lead the strategy of manufacturing improvements as they relate to product quality.

In order to execute the strategy, the position relies on two Engineering groups who are dedicated to the Product Improvements: NPI Quality Engineering and Customer Experience Engineering. These groups represent over 20 engineers. They conduct the technology research, and implementation of the strategy led by Product Quality Management in synch with R&D and Supply chain engineering. The position will lead the over-arching CAPAs on the topic.

On the other side of the spectrum the position is also accountable for short-term brand decisions. Any brand-wide deviation from the design intent will be reviewed and assessed. Product decisions in these cases are co-owned with the site quality leader. Will have signature authority on non-conformances and change control for assigned product lines.

• Accountable and signatory for quality plans, control plans, major changes and validations.
• Responsible for communicating to all levels of the organization and integrating the brand quality plan into the overall product value stream with specific and quantifiable business outcomes.
• This position is measured by the brand scorecard health which includes internal Quality metrics (NCs, Quality events), external Quality metrics (such as Customer complaints), Supply chain metrics (such as COGS) and Commercial metrics (such as adherence to BP).
• Adheres to environmental policy and procedures and supports department environmental objectives.

Qualifications

Education:

A minimum of Bachelor's or equivalent University degree is required, with a focus in Statistics, Engineering & Science preferred. Masters or advanced degree preferred.

Required:

• 8+ years working experience in Statistics/Process Engineering/Medical Device Industry (required)
• Excellent communication, interpersonal and organizational skills.
• Understanding of the NPI process.
• Thorough understanding of GMP/ISO regulations, validation regulations.
• Strong leadership, mentoring skills.
• Demonstrated management abilities.
• Demonstrated leadership ability over several functions.
• Business sense and experience.
• Able to build cost savings and growth business cases

Preferred:

• 3+ years experience in at least 2 of the 3 following domains: R&D, Manufacturing
• Excellent technical understanding of manufacturing equipment and processes
• Demonstrated experience in technical improvements process
• Understanding and application of principles, concepts and practices of statistical methods.

Other:

• This position may require up to 20% domestic & international travel
• The anticipated base pay range for this position is 118000 to 203550. California Bay Area - The anticipated base pay range for this position is 136000 to 234140.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year.
Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
-Vacation - up to 120 hours per calendar year
-Sick time - up to 40 hours per calendar year; Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability