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Quality Engineer (Franklin Site)

Job Purpose:

The Quality Engineer plays a vital role in ensuring the quality and safety of Company’s products throughout their entire lifecycle. They will leverage their expertise in quality engineering principles, industry standards, and regulatory requirements to contribute significantly to successful product development, manufacturing, and continuous improvement initiatives.

Job Responsibilities:

• Spearhead the development and implementation of effective procedures and pertinent standards, encompassing the establishment of best practices, formulation of inspection plans, crafting of test protocols, and devising data analysis procedures to ensure consistent product quality across its entire lifecycle.
• Supervise and conduct thorough inspections and audits of products and processes, proactively identifying and addressing potential quality issues. Analyze data trends to institute preventive quality measures, thereby minimizing defects and ensuring consistent product performance.
• Advocate for a proactive approach to risk management in accordance with ISO 14971 standards. Lead the site in identifying potential product risks, devising robust mitigation plans, and implementing controls to mitigate risks and ensure product safety.
• Oversee and actively participate in product testing and verification activities, ensuring alignment of all testing procedures with quality objectives and guaranteeing that products meet all functional and performance specifications prior to market release.
• Serve as a subject matter expert on current regulatory requirements (e.g., FDA) and industry standards (e.g., ISO 13485). Offer guidance and training to ensure compliance with applicable regulations throughout the product development and manufacturing processes.
• Collaborate with engineering functions to ensure that quality standards are integrated into products during the product development lifecycle and maintained throughout manufacturing processes.
• Define appropriate measures to ensure product and process quality.
• Identify opportunities to enhance quality processes across all departments. Lead and execute continuous improvement initiatives to optimize quality control practices and enhance overall product quality.
• Maintain awareness of current regulatory requirements and standards pertaining to product development and release, particularly in the medical devices sector.
• Knowledge of Design History File, Device Master Record, and Device History Record requirements according to ISO 13485:2016 and FDA 21 CFR 820 is preferred.
• Travel requirements: 25%, including international travel.

Job Qualifications/Requirements:

• Bachelor’s degree (B.S.) in an Engineering, Technical, or Scientific field.
• Minimum of 6 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience.
• Working knowledge of medical device development, including the Design Control Process.
• Proficiency in quality systems and quality assurance processes and principles, focusing on product development, verification and validation activities, and risk management activities (ISO 14971).
• Solid understanding of risk management processes (system risk analysis, Design Failure Mode and Effects Analysis (DFMEA)).
• CQE or Green Belt certification is preferred.
• Experience with statistical techniques (e.g., Design of Experiments (DOE), Analysis of Variance (ANOVA)) is preferred.
• Project management skills are preferred.
• Strong commitment to excellence and high standards.
• Excellent written and oral communication skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow effectively.
• Versatility, flexibility, and enthusiasm for working within constantly changing priorities.
• Acute attention to detail.
• Demonstrated ability to plan and organize projects.
• Ability to work independently and as a member of various teams.
• Proven ability to manage multiple projects and meet deadlines.
• Ability to develop clear, concise, and timely oral and written reports.
• Accurate completion of detailed forms and reports.

Job Purpose:

The Quality Engineer plays a vital role in ensuring the quality and safety of Company’s products throughout their entire lifecycle. They will leverage their expertise in quality engineering principles, industry standards, and regulatory requirements to contribute significantly to successful product development, manufacturing, and continuous improvement initiatives.

Responsibilities

• Lead the development and implementation of effective procedures and relevant standards. This includes establishing best practices, creating inspection plans, test protocols, and data analysis procedures to ensure consistent product quality throughout the entire lifecycle.
• Oversee and conduct comprehensive inspections and audits of products and processes. Proactively identify and address potential quality issues. Analyze data trends to implement preventative quality measures, minimizing defects and ensuring consistent product performance.
• Champion a proactive approach to risk management (ISO 14971). Lead the site in identifying potential product risks, developing robust mitigation plans, and implementing controls to minimize risks and ensure product safety.
• Oversee and participate in product testing and verification activities. Ensure all testing procedures are aligned with quality objectives and that products meet all functional and performance specifications before reaching the market.
• Serve as a subject matter expert on current regulatory requirements (e.g., FDA) and industry standards (e.g., ISO 13485). Provide guidance and training to ensure all products comply with applicable regulations throughout the development and manufacturing process.
• Collaborates with engineering functions to ensure quality standards are infused into product during the product development lifecycle and maintained within manufacturing processes.
• Defines appropriate measures to ensure product and process quality.
• Identify opportunities to enhance quality processes across all departments. Lead and implement continuous improvement initiatives to optimize quality control practices and drive overall product quality.
• Maintains knowledge of current regulatory requirements and standards as they pertain to the development and release of products, particularly medical devices.
• Knowledge of Design History File, Device Master Record, and Device History Record requirements according to ISO 13485:2016 and FDA 21 CFR 820 preferred.
• Travel requirements: 25% including international travel.

Job Qualifications/Requirements:

• Bachelor’s degree (B.S.) in an Engineering, Technical, or Scientific field
• Minimum of 6 years of relevant experience, or advanced degree with minimum of 4 years relevant experience
• Working knowledge of development for medical devices (Design Control Process)
• Working knowledge of quality systems and quality assurance processes and principles with a focus on product development and verification and validation activities and risk management activities (ISO 14971)
• Good knowledge of risk management processes (system risk analysis, DFMEA)
• CQE or Green Belt certification preferred.
• Experience with statistical techniques (e.g., DOE, ANOVA) preferred.
• Project Management skills preferred.
• Commitment to excellence and high standards
• Excellent written and oral communication skills preferred.
• Strong organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Acute attention to detail
• Demonstrated ability to plan and organize projects.
• Ability to work independently and as a member of various teams.
• Proven ability to manage multiple projects and meet deadlines.
• Ability to develop clear, concise, and timely oral and written reports.
• Accurately complete detailed forms and reports.

Bachelors