Job Description

A company specializing in the supply of plastic solutions is hiring a Senior Quality Engineer to provide leadership support by developing inspection methods to analyze product quality.

Some other key responsibilities include setting detailed guidelines on inspection and testing requirements, as well as ensuring products adhere to company and industry quality standards.

Responsibilities include:

• Identifies and leads CAPA and process improvement initiatives.
• Reviews and approves validation protocols and reports.
• Authors TMV protocols and reports.
• Reviews and approves calibration certificates and compliance reports.
• Develops, maintains, and monitors measurement processes to ensure compliance with ISO and FDA regulations.
• Collaborates with suppliers to investigate root causes and corrective actions when raw material or component deficiencies are detected.
• Monitors and evaluates supplier processes for compliance with purchase orders and engineering requirements.
• Deploys variation management tools and techniques at select suppliers to mitigate risk.
• Audits suppliers and establishes supplier quality requirements.
• Reports on supplier trends for management review and notifies management of identified trends for review.
• Designs and implements methods for process control, process improvement, testing, and inspection.
• Assists in new product transfer by developing quality inspection processes, DoE, risk assessment, TMVs, and validation efforts.
• Establishes and maintains process flow diagrams, workplace layouts, FMEAs, and standardized work instructions.

Job Requirements:

• Bachelor’s degree in an engineering field or related field. A master’s degree in engineering is preferred.
• 3-7 years of experience in the high-volume regulated manufacturing industry in the engineering field.
• Working experience with Six Sigma, lean, and Quality Management Tools.
• A broad knowledge of the theory and principles of statistics and statistical process control.Experience with Access Database, Excel, and complaint handling software.
• In-depth knowledge of ISO13485, ISO14971, CFR part 820.
• Good understanding of medical device regulation, industry, and international standards.
• Ability to read and understand technical drawings and documents.
• Working experience with CAD/SolidWorks.
• ASQ Lead Auditor or equivalent training in auditing.

Click apply or call on +1 (781) 214 8344 for more details.