Senior Manager, Product Quality Management

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Irvine California United States of America Milpitas California United States of America

Job Description:

Johnson & Johnson Vision a member of the Johnson & Johnson family of companies is recruiting for a Senior Manager Product Quality Management located in Irvine CA (Preferred) or Milpitas CA.

About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at 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 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:

• University / Bachelors Degree or equivalent is required. Bachelors Degree or equivalent in Statistics/Engineering/Science or Technical/MBA Degree or equivalent is preferred.

Experience and Skills:

Required:

• 8-10 years of experience in Medical Device Industry Statistics or Process Engineering.
• Excellent communication interpersonal and organizational skills.
• Understanding of the New Product Introduction (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 of experience in at least 2 of the 3 following domains: Quality R&D & Manufacturing.
• Understanding and application of principles concepts and practices of statistical methods.
• Excellent technical understanding of manufacturing equipment and processes.
• Demonstrated experience in technical improvements process.

Other:

• Up to 25% domestic and international travel is required.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Business Alignment Collaborating Compliance Management Fact-Based Decision Making Good Manufacturing Practices (GMP) ISO 9001 Mentorship Organizing Quality Auditing Quality Control (QC) Quality Management Systems (QMS) Quality Standards Quality Validation Regulatory Environment Standard Operating Procedure (SOP) Tactical Thinking Technical Credibility

The anticipated base pay range for this position is :

$122000 - $212750 The expected base pay range for this position in the Bay Area is $142000 - $244950

Additional Description for Pay Transparency:

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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: oVacation up to 120 hours per calendar year oSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year oHoliday pay including Floating Holidays up to 13 days per calendar year of Work Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.