Quality Inspector II

Johnson & Johnson Innovative Medicine • Arbutus, MD

6d • $22 - $34 • Onsite

About The Position

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.

Requirements

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

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees