Senior Manager Product Quality Management

Johnson & Johnson MedTech; Milpitas (CA); On-site; USD 122,000 - 213,000; Full time

Benefits offered by this job

Vacation time

Sick time

Parental Leave

401(k)

Job summary

Johnson & Johnson Vision in Milpitas/Irvine, CA is seeking a Senior Manager, Product Quality Management to lead brand quality from NPI through customer. The role partners with R&D, QA, regulatory and supply chain to drive ongoing quality strategy and improvements.

You will manage two engineering groups, oversee CAPAs, and sign off on major changes while ensuring regulatory compliance and business outcomes.

Qualifications

• 8+ years in Statistics/Process Engineering/Medical Device Industry.
• 3+ years in at least 2 of R&D, Manufacturing, Quality.
• Excellent communication and leadership, GMP/ISO knowledge.

Responsibilities

• Make key quality decisions on brands and strategic quality plans.
• Collaborate with commercial, regulatory and complaint handling to monitor performance.
• Guide NPI quality with R&D; assess launches for quality impact and timing.
• Lead CAPA program and drive quality improvements across supply chain.

Skills

Leadership

Quality Assurance

Statistical methods

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s Degree in Statistics/Engineering/Science

Bachelor’s Degree or Equivalent

Advanced degree Technical/MBA

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through 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 humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 Milpitas, CA or Irvine, CA. Preferred Location: Irvine, CA

Position Summary

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.

Education

• University / Bachelor’s Degree or Equivalent (required)
• Bachelor’s Degree in Statistics/Engineering/Science (preferred)
• Advanced degree Technical/MBA (preferred)

Experience And Skills

• 8+ years working experience in Statistics/Process Engineering/Medical Device Industry (required)
• 3+ years experience in at least 2 of the 3 following domains: R&D, Manufacturing (preferred), Quality
• Excellent communication, interpersonal and organizational skills.
• Understanding and application of principles, concepts and practices of statistical methods (preferred)
• Excellent technical understanding of manufacturing equipment and processes (preferred)
• Understanding of the NPI process.
• Demonstrated experience in technical improvements process. (Preferred)
• 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

Other

• Up to 10% domestic and international travel (required)

Required Skills

Preferred Skills:

The anticipated base pay range for this position is :

$122,000.00 - $212,750.00

For Bay Area

$142,000.00 - $244,950.00

Additional Description For Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Benefits

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits