Quality Engineer - temp

Contract position in Carlsbad for a medical device manufacturer is seeking a Quality Engineer who will be responsible to develop and implement systems to ensure products or services are designed and produced to meet or exceed customer expectations and regulatory requirements including the US Food and Drug Administration, Health Canada, European MDD / MDR and other as required.

This role will also participate in the implementation of improvements to the company's quality management system procedures including Nonconformance Material processes, Customer Compliant handling, Supplier Management, Process Validation, Measurement Systems Analysis and other quality engineering duties.

• Directly contribute to the implementation of the company's quality system processes related to CE Technical Files; including Risk Management Files, Clinical Evaluations, Post Market Surveillance and Periodic Safety Reports
• Perform and mentor others in performing thorough Root Cause Analysis, Corrective Action planning and implementation and Verification of Effectiveness planning and implementation
• This Corrective Action process will apply to internal nonconformities, product complaints, supplier quality issues, and will also provide engineering analysis and support in verification, validation and problem solving.

Key Responsibilities and Duties :

• Engages in continuous improvement; identify opportunities and recommending improvements.
• Provide ongoing quality engineering support through product lifecycle (including CAPA investigations).
• Drives supplier quality improvement; providing engineering analysis. Partner with key suppliers and manufacturing personnel to reduce defects, and participate in supplier selection including supplier quality audits.
• Conduct trend analysis and provide business impact analysis.
• Develops processes of metrics, established Key Process Indicators.
• Provide quality engineering insight and guidance on product development, improvement and process improvement projects.
• Plan, control and assure product and process quality in accordance with quality principles and best practices.
• Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements.
• Stays current with validation regulatory requirements.
• Participates in special projects and perform other duties as required. Required Qualifications and Experience :
• 5+ years of related experience
• Bachelors Degree in related discipline
• May hold one or more industry certifications
• Strong working knowledge of medical device regulations including ISO 13485 : 2016, 21CFR820, MDR and other global regulatory requirements.
• Success in the implementation of problem-solving methods and tools.
• Understand effective implementation of the entire risk management process (identification and implementation of appropriate controls in product development and / or operations).
• Experienced in product verification / validation, process validation and test system development and implementation - meant to satisfy quality and regulatory standards in the medical device industry.
• Experienced with the implementation of statistical tools and techniques.
• Experienced in developing appropriate trending related to operational and product quality. Driving improvement through root cause analysis and CAPA projects.
• Strong understanding of best practices related to supplier quality and development.
• Knowledgeable in computer system validation and related regulatory requirements. Skills and Competencies :
• Strong understanding of industry practices
• High proficiency with tools, systems and procedures
• Good planning / organizational skills and techniques
• Good decision making, analysis and problem solving skills with ability to multi-task
• Strong verbal and written communication skills
• Good presentation and public speaking skills
• Good interpersonal skills
• Good conflict resolution skills and ability to deliver difficult messages
• Ability to build partnerships at all levels within the company, begin to build partnerships externally
• Resolve complex issues in effective ways Location : Carlsbad, Ca

Schedule : Monday thru Friday

Length : End in December 2024

Compensation : $30-40 / hr depending on related experience and skills