Calibration Technician V

Worklane GmbH; Kirkwood (MO); On-site; USD 55,000 - 74,000; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Tuition reimbursement

Paid time off and holidays

Job summary

Worklane GmbH is seeking a Calibration Technician to support the IMTE calibration program across St. Louis facilities.

You will collaborate with R&D, Manufacturing Eng, and Manufacturing to ensure compliance with directives and procedures, and maintain calibration records with accuracy. You will coordinate internal and external calibration services, review contractor certificates for completeness, and document out-of-tolerance events to support CAPA investigations, while preparing for internal

Qualifications

• Four or more years performing calibration activities and coordinating external lab services.
• Experience documenting and reporting calibration discrepancies and NCRs.
• Familiarity with ISO 13485, ISO/IEC 17025 and FDA QMSR requirements.

Responsibilities

• Collaborate with R&D, Manufacturing Eng, and Manufacturing to support IMTE calibration.
• Enter and maintain calibration asset data in the tracking system.
• Coordinate scheduled calibration activities per directives and procedures.
• Schedule internal and outsourced calibration services.
• Generate, maintain, and archive calibration records.
• Review contractor calibration certificates for compliance.
• Document out-of-tolerance events and support CAPA actions.
• Create nonconformance records and assist investigations.
• Communicate calibration schedules and equipment issues to teams.
• Assist with audits related to calibration and equipment management.

Skills

Attention to Detail

Mechanical Aptitude

Electrical Aptitude

Calibration Expertise

Regulatory Knowledge

Communication Skills

Problem Solving

Education

High school diploma or equivalent

Associate degree preferred

Bachelor's degree preferred

Tools

Blue Mountain RAM software

Job description

Objective

Maintain the calibration system for test and measurement equipment across St. Louis facilities.

Responsibilities

• Collaborate with cross-functional teams, including R&D Engineering, Manufacturing Engineering, and Manufacturing, to support the Inspection, Measuring, and Test Equipment (IM&TE) calibration program in accordance with established directives, procedures, and policies.
• Accurately enter and maintain calibration asset data in the asset management tracking system.
• Perform and coordinate scheduled calibration activities in accordance with global directives, applicable regulations, and established procedures.
• Schedule and coordinate all internal and outsourced calibration services.
• Generate, maintain, and archive calibration records.
• Review contractor calibration certificates for completeness and compliance with established requirements.
• Document out-of-tolerance events and support root cause investigations and corrective actions.
• Create nonconformance records and assist with associated investigations and product/equipment dispositions.
• Communicate calibration schedules, equipment failures, and missing test equipment to affected departments.
• Follow standard operating procedures and provide recommendations for updates to work instructions and processes.
• Support internal and external audits related to calibration and equipment management activities.
• Maintain reliable transportation and a valid driver's license to support local travel requirements.
• Travel locally to multiple company facilities and calibration/metrology service providers as needed.

Required Education & Experience

• High school diploma or equivalent with a minimum of four (4) years of experience performing calibration activities and coordinating calibration services with external laboratories.
• An Associate degree may substitute for two (2) years of the required experience.
• Associate or Bachelor's degree in a technical discipline preferred.

Required Skills & Qualifications

• Attention to Detail – Accurately documents calibration activities, discrepancies, and anomalies, and escalates out-of-tolerance conditions in accordance with established procedures.
• Mechanical Aptitude – Proficient in the use of precision measuring devices, including calipers, micrometers, and mechanical test fixtures.
• Electrical Aptitude – Proficient in the use of multimeters, variable autotransformers, electrical safety analyzers, and related test equipment.
• Calibration Expertise – Experienced in performing calibrations and maintaining calibration systems in accordance with established procedures and regulatory requirements.
• Regulatory Knowledge – Familiar with medical device calibration requirements within ISO 13485, ISO/IEC 17025, and applicable FDA Quality Management System Regulations (QMSR).
• Communication Skills – Effectively communicates technical information, reports out-of-tolerance findings, and participates in nonconformance investigations and corrective action activities.
• Problem Solving – Demonstrates the ability to analyze calibration discrepancies, identify root causes, and support effective corrective and preventive actions.

Preferred Qualifications

• ASQ Certified Calibration Technician (CCT) certification.
• Experience in a medical device or pharmaceutical manufacturing environment.
• Experience using Blue Mountain RAM software.
• Familiarity with 21 CFR Part 11 requirements for electronic records and electronic signatures.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.

Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or take over sponsorship of an employment Visa at this time.