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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 https://www.jnj.com

Job Function:

Quality

Job Sub** **Function:

Quality Control

Job Category:

Business Enablement/Support

All Job Posting Locations:

Halethorpe, Maryland, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re 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 https://www.jnj.com/medtech

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 https://www.jnj.com/ .

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Quality Inspector II.

JOB SUMMARY

The Quality Inspector will perform inspections, checks, tests, review of quality documents such as a device history report and sampling procedures of incoming materials, parts/components, partially assembled or finished medical devices. Provide support to Engineering and the Operations group as needed.

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

+ Perform inspections of purchased parts, subassemblies or finished company product according to criteria using standard visual, physical, mechanical, and/or electrical measurements

+ Ability to perform visual inspection on large lots of complex components under a microscope.

+ Perform mechanical inspection using advanced inspection systems which included using a vision and or touch probe system

+ Accurately document inspection and testing results to record components acceptance or rejection • Conduct and document process and system audits using written procedures as audit standards

+ Maintain all controlled document files and test records in a timely and accurate manner

+ Coordinate calibration of department test equipment and fixtures

+ Perform data entry into associated data systems. SAP knowledge preferred

+ Monitor critical equipment and instrumentation to ensure proper operation and calibration. • Participates in construction and/or revising SOP’s, inspection procedures, protocols, and checklists

+ Assist engineers in developing or improving inspection processes and check list as problems or opportunities are identified

+ Identify and evaluate problems and make initial recommendations for possible corrective action to the supervisor

+ Responsible for communicating business related issues or opportunities to next management level • Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

+ Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

+ High School graduate or equivalent required. Associate Degree in a technical field preferred • 8 plus years experience in quality inspection. Medical device experience preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

+ Strong ability to perform complex mechanical inspection (may assist engineering with problem solving, fixture design, setups and quality plans)

+ Perform mechanical inspection using advanced systems which includes using vision and touch probe

+ Perform electrical and optical cable and sensor testing

+ Extensive knowledge in Geometric Dimensioning & Tolerance

+ Extensive knowledge in IPC – 610 • Ability to use all inspection gages, electrical test equipment and microscope

+ Knowledge in ISO and GMP. US FDA 21 CFR QSR and ISO 13485

+ Attention to detail with the ability to follow SOPs and inspection procedures • Strong math and verbal/written communication skills

+ Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives

+ Ability to lead and execute tasks in a timely manner with no supervision

+ Ability to lead and adapt to changing business needs and department priorities

+ Proficient in SAP desired and knowledge of Microsoft Office

Additional Information:

+ The expected base pay range for this position is 21.63 - 34 / hr

+ 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.

+ This position is overtime eligible.

+ This position is eligible for a shift differential.

+ 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)).

+ This position is eligible to participate in the Company’s long-term incentive program.

+ Employees are eligible for the following time off benefits:

+ o Vacation –120 hours per calendar year

o Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

o Holiday pay, including Floating Holidays –13 days per calendar year

o Work, Personal and Family Time - up to 40 hours per calendar year

o Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

o Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member

o Caregiver Leave – 10 days

o Volunteer Leave – 4 days

o Military Spouse Time-Off – 80 hours

+ Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

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.

\#LI-Onsite

Required Skills:

Preferred Skills:

Administrative Support, Agility Jumps, Communication, Compliance Management, Customer Centricity, Document Management, Execution Focus, Factory Acceptance Test (FAT), Persistence and Tenacity, Process Oriented, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Teamwork