Quality Assurance Analyst

Straumann • Mansfield, TX

225d

About The Position

The Quality Assurance (QA) Analyst provides quality assurance support to ensure that CADCAM products meet quality requirements. The candidate collaborates with cross-functional teams to monitor operational processes to ensure compliance with applicable Quality System Regulations and ISO Standards. Coordinate and support Quality QMS system and processes, including audit program, document control, training, CAPA, record retention, nonconformity, and customer complaint investigation.

Requirements

• Bachelors degree in Engineering
• 2+ years of quality assurance experience, preferably in the medical device manufacturing field
• 2+ years of experience utilizing GDP/GMP requirements
• 2+ years of experience utilizing Microsoft Office Suite or similar software.

Nice To Haves

• Familiarity with US and International medical device regulations.
• Ability to support/assist other departments than quality for investigation, collecting metrics.
• Basic quality tools including RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts.
• 2+ years of experience with US and International medical device regulations.
• Excellent listening skills.
• Excellent analytical and problem-solving skills.
• Ability to learn production sequences and the company's quality standards.
• Excellent written and verbal communication skills.

Responsibilities

• Provides entry-level support to quality department.
• Reviews quality trends based on collected quantitative data and interactions with quality inspectors and operations personnel.
• Acquires skills and experience necessary to perform Quality Assurance tasks without supervision.
• Support to maintain the company's Quality Management System (QMS) processes and procedures and records required to manage product and regulatory requirements.
• Collaborates with the process owners and Subject Matter Experts to generate new documents or update documents to comply with industry regulations and corporate requirements.
• Assist quality improvement projects by participating and supporting project teams, resources, stakeholder relationships, timelines, and milestones.
• Assist the company training program, nonconformity (NCR); SCAR (Supplier Corrective Action Request) programs.
• Execute incoming inspection and raw materials release.
• Manages and maintains supplier performance in coordination with multidisciplinary team.
• Monitor and support the multidisciplinary team to implement the CAPA program.
• Conduct customer complaint investigations, implement correction or corrective action as required.
• Coordinate and prepare site audit from health authority, notified body and key customers.
• Accurately records and reports of information as required.
• Support change control, technical transfer, or new product introduction in coordination with multidisciplinary team.
• Assists in maintaining the company Risk Management programs.
• Assist in product and process validation as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree