Osteogenics Quality Associate (On-Site Lubbock, TX)

Envista Dentistry•Lubbock, TX

50d•Onsite

About The Position

JOB SUMMARY : The Quality Associate provides quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards. PRIMARY DUTIES & RESPONSIBILITIES: Review device batch records for accuracy and compliance to established specifications release product into finished goods inventory. Supports quality management when quality management system improvements are needed and help develop new procedures or update existing ones to prevent a potential issue or improve a process. P rovides guidance to manufacturing staff on QMS policies and inspections. Responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development. Manage process and product non-conformances in line with company procedures. Conducts quality assurance tests to ensure product specifications are met. Reviews, investigates, resolves and reports on quality discrepancies. Develops, maintains, monitors, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards. Monitors, investigates, and reports on customer complaints. Obtains the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development. Supports for audit and inspection preparation, resolution of audit and inspection findings. Interacts frequently with other functional areas and operating entities.

Requirements

High school diploma/Associate’s degree with equivalent experience in a similar role.
3+ years of experience working in a Quality position within an FDA regulated industry (ex: tissue banking, medical device, biologics or pharmaceutical industries

Nice To Haves

Bachelor’s degree in a Science, Business, or a Technical field preferred but not required.
Prior experience with batch record reviews, managing non-conformances.
Ability to monitor, investigate, and report on customer complaints.
Prior experience working at a tissue bank or as an AATB Certified Tissue Bank Specialist preferred.
ASQ Certified Quality Auditor certification.
Six Sigma Certifications: Green Belt, Yellow Belt.

Responsibilities

Review device batch records for accuracy and compliance to established specifications release product into finished goods inventory.
Supports quality management when quality management system improvements are needed and help develop new procedures or update existing ones to prevent a potential issue or improve a process.
Provides guidance to manufacturing staff on QMS policies and inspections.
Responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development.
Manage process and product non-conformances in line with company procedures.
Conducts quality assurance tests to ensure product specifications are met.
Reviews, investigates, resolves and reports on quality discrepancies.
Develops, maintains, monitors, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards.
Monitors, investigates, and reports on customer complaints.
Obtains the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development.
Supports for audit and inspection preparation, resolution of audit and inspection findings.
Interacts frequently with other functional areas and operating entities.