Senior Quality Control Tech

bioMerieux Inc.; Hazelwood (MO); On-site; USD 26,139 - 37,229; Full time

Benefits offered by this job

Medical plan

Dental plan

Vision plan

Life Insurance

Disability Insurance

Retirement Plan

Adoption Assistance

Wellness Programs

Employee Assistance Program

Commuter Benefits

Voluntary benefits

Discount programs

Parental leaves

Job summary

bioMerieux Inc. is seeking a QC Technician to conduct inspections, audits, and final releases of components, raw materials, in-process items, and finished devices.

You will ensure calibration of equipment, proper documentation, and segregation of nonconforming materials while supporting deviation resolution and site compliance. The role requires interpreting specifications, applying rigorous QC methods, and training teammates.

Qualifications

• High School Diploma, GED or equivalent
• 4+ years of related experience in a Quality Control setting having competence in the use of Quality Dimensional Tools and Techniques and advanced knowledge of quality systems (SAP/LIMS/Trackwise).

Responsibilities

• Performs a wide variety of inspection, audit and release activities.
• Interprets requirements and uses sound judgment to determine compliance.
• Investigates nonconformances and interfaces with technicians/engineers to diagnose and remedy issues.
• Maintains setup/inspection of components, raw materials, in-process and finished product per specifications.
• Ensures nonconforming, Line Throw Off, and Purged material is segregated and secured per site/regulatory requirements.
• Performs in-process inspections and audits to support Instrument Manufacturing; reviews records prior to release.

Skills

QC experience

Dimensional tools

QA systems knowledge

Education

High School Diploma, GED or equivalent

Tools

SAP

LIMS

TrackWise

Job description

Position Summary

Conducts activities within the Quality Control functions of Incoming Inspection of components and raw materials (ensuring that materials meet specifications), In-Process audits (ensuring that manufacturing operations remain in control), and the inspection and release of finished product, as appropriate. The job entails ensuring equipment is maintained / calibrated as appropriate, departmental documentation is current and accurate. Responsible for ensuring deviations are properly documented, nonconforming material is segregated and secured, and the supporting of any projects assigned. Performs all duties using safety conscious practices. Individual must inspect/test/audit materials & processes in a timely fashion while, at the same time, ensuring conformance to all requirements.

Primary Duties

• Performs a wide variety of inspection, audit and release activities.
• Written procedures, blueprints, standards and regulations that define requirements assume a significant degree of experience and understanding on the part of the QC Technician of inspection techniques, appropriate inspection equipment, principles of sampling, data analysis, auditing, and the theory of operation and function of the various instruments.
• Inherent in the process of inspection is the interpretation of requirements, and the need to use careful judgment to determine compliance. It is critical for individuals in this role to use sound judgment and demonstrate consistent decision-making.
• Performing the QC testing routinely results in the need to investigate nonconformances, and either independently address them, or interface with technicians and/or engineers to diagnose and remedy the problem.
• Understands operational priorities, "hot parts" lists, and the daily/weekly instrument production schedule to meet the needs.
• Responsible for the timely setup and inspection of components, raw materials, in-process, and release of finished product in accordance with specifications. Interprets blueprint requirements and confirms conformance to specifications. Leads in the standardization and advancement of inspection methods. Train new and existing QC Technicians.
• Maintain's thorough knowledge of the transactions in the ERP system for movement of materials.
• Transport conforming parts to inventory, including all computer transactions and written record completion. For materials found to be nonconforming, generates "nonconforming material reports", requiring a technically accurate description of the anomalies.
• Responsible for ensuring nonconforming, Line Throw Off, and Purged material is segregated and secured including the disposition of non-conforming materials meet all necessary site and regulatory requirements.
• Perform Quality Control in-process inspections & audits necessary to support Instrument Manufacturing. Assesses subassemblies, finished devices, and the assembly & test processes for conformance to documented requirements.
• Perform final inspections of completed medical devices and accessories, including the detailed review of the Device History Record package to confirm the completeness and accuracy of records prior to formally releasing the instrument for distribution.
• Execute complex First Article Inspections.
• Responsible for ensuring that QC Inspection Methods are current and accurate.
• Maintains thorough understanding of all specifications, requirements, and procedures and provides input regarding the continuous improvement of each.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Qualifications

• High School Diploma, GED or equivalent
• 4+ years of related experience in a Quality Control setting having competence in the use of Quality Dimensional Tools and Techniques and advanced knowledge of quality systems (SAP/LIMS/Trackwise).

Preferred Qualifications

• Must have an advanced knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
• Expert ability to use precision mechanical measuring instruments, coordinate measuring machine, optical comparators, microscopes, measure scopes, meters and other various electrical test equipment. Expert ability to read and interpret complex blueprints, a plus would be the knowledge of Geometric Dimensioning & Tolerancing (GD&T).

Knowledge, Skills, and Abilities

• Consistently upholds and reflects the core ethical principles and values that bioMerieux promotes.
• Effective verbal communication skills
• Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
• Informing others by sharing clear, timely information to ensure alignment.
• Troubleshooting issues to identify and resolve problems efficiently
• Critical thinking, using logic and reason to analyze information and make decisions in the workplace.
• Advanced: demonstrates deep knowledge; manages complex tasks and integrates multiple tools independently
• Ability to complete projects with limited supervision in a timely fashion

Supplemental Data (Summary)

This position impacts the manufacturing life cycle Quality Control for products produced in St. Louis. Failure to properly execute Quality Control inspections, tests, or analyses on the part of this position could directly result in a product recall. Operating within clearly defined guidelines, is empowered to make decisions impacting product quality, quality records, deviation resolution, and site compliance.

Working Conditions (Summary)

• Ability to ascend/descend stairs, ladders, ramps, and the like: Yes
• Ability to wear PPE correctly most of the day: Yes
• Ability to adjust or move objects up to 50 pounds in all directions: Yes
• Must be able to push a wheeled cage that can weight up to 600 lbs.
• May operate within cool temperatures and low humidity.
• Constant noise is common due to equipment.

Compensation

The starting pay for this role in the state of Missouri is $23.00/hr. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.

Benefits

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match.
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves

Equal Opportunity Statement

BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at [phone], by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).