Quality Lead - 3rd Shift

Comar•Buena Vista Township, NJ

11h•Onsite

About The Position

The Quality Lead will perform Quality Technician and Quality Inspector duties, including inspection/testing, audit, calibration, quality document control management, and data collection system setup and maintenance. This role involves reviewing batch records, COAs, and incoming materials, managing controlled documents, performing validations, conducting GMP and line audits, and writing deviations and nonconformance reports. The Quality Lead will also train quality and production staff, develop and onboard Quality Technicians, and maintain a clean and safe work environment. Additional responsibilities include supporting ISO 13485 and cGMP requirements, and for SQF Certified Sites, understanding cGMPs, Good Hygiene Personnel Practices, performing basic sanitation functions, and identifying and controlling food safety and quality issues. The role requires adherence to safety policies and wearing PPE.

Requirements

High school or Vo-Tech graduate with 6+ years of experience in Quality Control OR an Associate degree in a scientific discipline with 4+ years of Quality Control experience.
Experience in an ISO certified or regulated environment.
Proficient with computers, software, and Statistical Process Control (SPC) tools and techniques.
Proficient with Gauge Repeatability and Reproducibility (Gauge R&R).
Proficient with process validation tools and techniques and familiarity with ISO 9001 and/or ISO 13485.
Experience in onboarding, developing and training new quality technicians on all processes, standard operating procedures, tools and techniques, as well as computers, SPC and Guage R&R.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to work independently and in a team environment.
Skilled at learning the use of equipment for dimensional analysis.
Detail-oriented/capability of discovering nonconformances in both paperwork and materials.
Ability to apply basic math skills: add, subtract, multiply, divide. Compute rate, ratio, percent.
Ability to carry out instructions provided in written, oral, or visual / diagram format.
Ability to communicate their job related functions with other employees, cross-department, with customers and auditors as needed.
Ability to write routine reports.
Ability to interact with manufacturing associates in a meaningful way to ensure collaboration and trust.
Ability to troubleshoot and diagnose measurement system errors.
Ability author work instructions for quality related materials and processes (e.g. SPC, Calibration, Gauge R&R and Testing).
Ability to interpret product drawings and specifications.
Ability to speak effectively before groups of customers or employees.
Displays strong leadership and organizational skills.
Ability to onboard, develop and train Quality Technicians I, II and III.
Ability to prioritize, plan, organize and coordinate work across Quality Technicians I, II, III.
Ability lead quality improvement projects.
Ability to lead the quality team in absence of management.
Effectively communicate with supervisor.
The ability to read, write, and comprehend information provided.

Nice To Haves

Bachelor’s degree in science, technology, engineering or significant applicable experience, training, and certifications.
Experience working in medical device, food manufacturing, or clean room environments and experience working in a GMP quality role.
Experience with environmental monitoring and visual inspection standards and processes.
Knowledge of Regulated Industry: CFR Part 820 Quality System Requirements, the ISO family of standards, particularly ISO 13485 and 9001, and others as needed.
Knowledge of the safety requirements and complexity of working with automated and semi-automated production and inspection systems in a factory environment.

Responsibilities

Perform Quality Technician and Quality Inspector duties, including inspection/testing, audit, calibration, quality documents control management, data collection system set up and maintenance.
Perform quality review of all completed batch records and provide explanations of required corrections to manufacturing operations and QC inspectors.
Maintain batch records.
Review COAs and perform any required testing/inspection for all incoming materials.
Perform maintenance of controlled documents, including work instructions, SOPs, training records, etc.
Administer the document change process for new work instructions, SOPs, etc.
Act as an SME for the IQMS system with regards to document control.
Complete inspections/data charts for mold qualifications and special quality assurance projects.
Perform Tool/Line validation protocol and compile results.
Conduct GMP (Good Manufacturing Practice) and line audits.
Manage Certificates of Conformance / Analysis process; Process customer sales samples.
Generate COCs for Comar finished products.
Write deviations and nonconformance reports as required, assist operations with investigations, root cause analysis, and determining corrective actions.
Train quality and production staff on defect recognition and quality assurance processes.
Develop, Train and Onboard Quality Technician I, II, III.
Effectively operate equipment as required.
Maintain a clean and safe work environment.
Provide support and guidance to operations on the floor with respect to ISO 13485 and cGMP requirements.
Support ISO 13485 and cGMP awareness, training, and monitoring.
Have a basic understanding of the cGMPs and Good Hygiene Personnel Practices.
Notify SQF Practitioner and/or Supervisor of any repairs or adjustments that are required.
Perform Basic Sanitation Functions.
Perform all duties necessary to meet Company, and or Regulatory Requirements / standards as prioritized by the Company, HACCP, and SQF.
Notify SQF Practitioner/Quality Manager or any other Management personnel of ANY Food Safety or Quality issues.
Identify problems relating to Food Safety and the Quality of the raw material, processes, quality system, or safety system, by performing Production/Quality Checks as assigned.
Ability to initiate action to prevent the occurrence of nonconformities relating to Food Safety and the Quality of the product, processes, quality system, or safety system.
Be able to execute and follow the HOLD SOP.
Controls further processing or delivery of nonconforming product in terms of Food Safety and Quality issues until the deficiency or unsatisfactory condition has been corrected.
Employee follows all Food Fraud/food Defense Policies while on company property.
Thorough understanding of all Company policies, including GMP’s and safety policies, HACCP & SQF.
Adhere to safety policies.
Maintain a clean and safe work area and report any unsafe conditions to supervisor.
Wear company issued personal protective equipment (PPE) such as uniforms, gloves, hairnets.
Other duties as assigned.