Staff Quality Engineer Jobs

Staff Quality Engineer-2307007447W

Description

Kenvue is currently recruiting for Staff Quality Engineer. This position reports into Quality Manager and is based at Skillman, NJ

Who We Are

At Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® —are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.

Join us in shaping our future-and yours.

Watch us here:

What will you do

The Staff Quality Engineer is responsible for the oversight of external manufacturing (EM) co-packing sites supporting the trade customization and make-to-stock businesses across multiple regulatory class products for the U.S. market.

Key Responsibilities

• Ensures compliance to supplier management business processes.
• Leads internal/external oversight of third-party external/trade customization manufacturing sites that package medical device, drug/OTC, food/dietary supplements, and cosmetic products. Assesses and improves compliance at external manufacturing sites based on FDA requirements (21CFR Part 210, 211 and 820) and Kenvue standards of quality to maintain acceptable audit ratings.
• Influences sites to improve compliance profile, where identified. Performs and assesses EM investigations to include detailed root cause analysis and corrective/preventive actions. Drafts, reviews, approves change controls, investigations and/or CAPAs where necessary.
• Accountable to end-to-end (receiving to finished product quality) processes at EM sites and ensuring supply chain continuity. Additional responsibilities also include distribution center resolution of nonconforming product and consumer complaint investigation remediation and guidance.
• Leads quality business reviews with EMs and business partners. Compiles, monitors, and assesses quality metrics (KPI’s) through to documenting, implementing, and reporting improvements.
• Manages and leads teams as subject matter authority for Quality on new product launches and/or compliance remediation initiatives. Requirements included: review and approval/rejection of product trials, protocols, qualifications, completion reports, FAIs, change controls and new product introductions.
• Accountable for performing batch records reviews to assign product disposition and release in SAP. Audits all GXP documentation and provides timely resolution on any discrepancies.

Qualifications

What we are looking for

Required Qualifications

• Well-organized and able to prioritize in a fast-paced environment, demonstrating dedication to key business objectives
• Experience with working with external manufacturers
• Minimum of a Bachelor’s degree or equivalent in science related discipline
• Ability to coordinate and analyze technical data and identify issues or gaps
• Applies risk-based principles for strategic and tactical problem solving
• Self-motivated and committed to a team approach
• Strong interpersonal, written, and verbal communication and analytic skills
• Versed in CFR/ICH/ISO compliance guidelines
• Minimum six (6) years of experience in a Quality role supporting consumer products or equivalent
• Attention to detail and the ability to lead multiple projects simultaneously

Desired Qualifications

• Ability to provide innovative solutions to complex situations and projects
• Demonstrated ability to interpret and understand health authority regulations
• Proficient in SAP, Trackwise, and EtQ quality systems
• Managed compliance profiles of various regulatory classes, i.e. cosmetics, OTC/drug, medical device, and food/dietary supplements

Other:

• This position requires up to 10% travel based upon business needs

What’s in it for you

• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
• Competitive Benefit Package
• Learning & Development Opportunities
• Employee Resource Groups

The anticipated base pay range for this position is $102,000- $163,300.

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

Primary Location NA-US-New Jersey-Skillman

Organization JNTL Consumer Health LLC

Travel Yes, 10 % of the Time

Job Function Quality (Eng)