Quality Assurance Specialist

Human Resources•Whitsett, NC

11d

About The Position

The Quality Assurance Specialist maintains Berkshire’s quality inspection and product release programs for incoming and in-process materials, components, processes, finished goods, and product returns. The role plans and oversees inspections and testing, maintains quality records, documents quality activities, communicates significant issues and improvement recommendations, and prepares reports and technical information for team members and management. The specialist also supports supplier reviews, third-party testing, sterility documentation, certificates, product returns, ISO documentation and audits, and nonconforming material and corrective/preventive action processes. The position applies Lean, Six Sigma, and root-cause analysis to improve efficiency, quality, delivery, and waste reduction, working with department leaders on improvement activities. The ideal candidate is detail-oriented, professional, proactive, and able to work independently and collaboratively with minimal supervision. The position requires the time necessary to meet job requirements, including 40+ hours per week, possible weekday and Saturday overtime, and flexible hours between 6 a.m. and 6 p.m. for production runs. The work includes operating computers and testing equipment, frequent standing, walking, sitting, and reaching, occasional lifting up to 25 pounds, and work in a moderate-noise environment and occasionally in a non-temperature-controlled warehouse. Gowning for ISO Class 7, 4, and 6 environments may be required.

Requirements

Bachelor’s degree from an accredited college or university, or three to five years of related experience and/or training, or an equivalent combination.
Excellent organizational skills.
Knowledge and experience with Six Sigma and root-cause analysis.
Ability to prepare and present information effectively in one-on-one and small-group situations.
Ability to interpret written, oral, diagrammatic, or schedule-based instructions and apply complex conditional instructions.
Ability to use mathematics with drawings, specifications, charts, and tables.
Good working knowledge of MS Office and ERP system software.
Ability to use precision measuring instruments and a personal computer to input data.
Excellent analytical, problem-solving, and decision-making skills.
Proficiency in testing, version control, and defect-management best practices.
Environmental monitoring experience involving air, water, surfaces, and personnel.
Ability to communicate and work well with all organizational levels and to perform responsibilities with minimal supervision.
Professionalism, integrity, a positive attitude, attention to detail, and an appropriate sense of urgency in responding to production and customer needs.
Ability to assist with IQ/OQ/PQ validations and maintain confidentiality in matters involving security and/or manufacturing.
Willingness and ability to keep skills and industry knowledge current.
Ability to work 40+ hours per week, work overtime during the week and on Saturdays, and work flexible hours between 6 a.m. and 6 p.m. for production runs.
Ability to perform the described physical tasks, including handling testing equipment and product, operating a computer, and occasional lifting and moving of up to 25 pounds.

Nice To Haves

LIMS/QMS experience.
Experience in the textile industry, including knitting, finishing, or yarns; experience with knits and nonwovens.
Previous experience with an ISO 9001 system in a manufacturing environment.
Cleanroom experience in ISO Class 4–8 environments.
Experience with precision measuring instruments.

Responsibilities

Interpret, build upon, and comply with company quality assurance standards.
Maintain complaint and nonconformance processing through records and tracking systems, including root-cause analysis and corrective actions.
Document quality assurance activities through internal reporting and audits; collect, analyze, and graphically present quality data.
Create product certificates, including Certificates of Sterility, Certificates of Conformance, and Certificates of Analysis as required.
Perform receiving, in-process, and final inspections.
Maintain inspection and product-release programs for incoming and in-process materials, components, processes, finished goods, and product returns.
Plan, execute, and oversee product inspections and testing for quality and conformance to specifications and deliverables.
File and maintain Quality Department records in written and electronic form.
Review purchased products or components against inspection plans and provide input on acceptance and future supplier purchases.
Communicate significant quality issues and developments and recommend process improvements to management.
Prepare reports and present technical and program information to team members and management.
Maintain working knowledge of applicable government and industry quality assurance codes and standards.
Generate purchase orders, prepare products for third-party testing, and obtain and distribute test reports.
Review sterility documentation, generate batch reports, and prepare Certificates of Sterility.
Handle the product returns process.
Assist with preparing, revising, and distributing ISO documentation; schedule internal audits, support internal auditors, and assist with third-party audits.
Initiate and monitor Non-Conforming Material and Corrective/Preventive Action processes in NC.
Monitor processes and develop improvements to increase efficiency, quality, and on-time delivery and reduce waste.
Use Lean, Six Sigma, and root-cause analysis techniques and work with department leaders on kaizen and Six Sigma improvement activities.
Perform other duties as assigned by the Quality Supervisor and/or Quality Manager.
Build and share knowledge and skills, seek outside training and professional organization membership, and adhere to Berkshire’s Code of Conduct and Professional Ethics Standards.