Senior Manager Product Quality Management

Antler; Irvine (CA); On-site; USD 122,000 - 213,000; Full time

Benefits offered by this job

Vacation 120 hours per calendar year

Sick time 40 hours per calendar year

Holiday pay 13 days per calendar year

Parental Leave 480 hours within one年

Job summary

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.

Working with Supply Chain, R&D, QA and commercial leadership, you will lead monitoring, analysis and improvement of brand quality from NPI to customer, shaping the quality strategy and ensuring compliance with GMP/ISO. Travel up to 10%.

Qualifications

• 8+ years in Statistics/Process Engineering/Medical Device Industry.
• 3+ years in at least 2 of: R&D, Manufacturing, Quality.
• Excellent communication, interpersonal and organizational skills.
• Understanding GMP/ISO regulations and validation practices.

Responsibilities

• Partner with commercial org, regional offices, Regulatory and Complaint handling to gather short and long term information on brands and field performance.
• For new products, collaborate with R&D leadership to modify development to optimize product quality and assess launches.
• For existing products, partner with Supply Chain to assess and implement manufacturing improvements related to quality.
• Lead CAPAs and sign-off on quality plans, changes and validations; communicate brand quality plans across the organization.

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, and solutions 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

• 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)

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 https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

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