Senior Quality Engineer

BD; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Quality Assurance & Data Analyst to enhance its Quality team. This role is pivotal in ensuring compliance with medical device regulations while driving innovative solutions through data analysis. The ideal candidate will leverage their auditing skills and experience in digitizing processes to streamline operations and improve efficiency. Join a collaborative environment where your analytical expertise will directly impact health care advancements. If you are passionate about quality assurance and looking to make a difference in the medical technology field, this opportunity is perfect for you.

Qualifications

• 4-6 years of experience in quality assurance and data analysis.
• Strong knowledge of medical device regulations and auditing.

Responsibilities

• Lead quality systems activities ensuring regulatory compliance.
• Collect and analyze data to improve quality operations.

Skills

Auditing medical device regulations

Data analysis

Process digitization

Communication skills

Analytical skills

Education

Bachelor’s degree in engineering

Tools

Tableau

Power BI

Minitab

R

Python

Job description

Job Description Summary

Job Description

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

About BD TCI

“BD, a 125-year-old global medical device company has started its Enterprise Center in Bangalore, India called BD Technology Campus India (TCI). This Enterprise Center will be an integral part of the global network for BDX. It will have presence of R&D, Quality, Regulatory, IT and other functions. The center boasts of some of the brightest minds who work in a unique environment that fosters and supports ingenuity. BD TCI is dedicated to serving BD’s customers and patients thereby contributing its bit towards “advancing the world of health”.

Job Summary:

We are seeking a skilledSenior Quality Assurance & Data Analystto join our Quality team. The ideal candidate will have a strong background in digitizing processes and developing innovative solutions, with experience in the medical device industry being a plus. This role involves collecting, analyzing, and interpreting complex data to support decision-making and improve operational efficiency. Additionally, the candidate will perform QA activities to ensure compliance with applicable standards and medical device regulatory requirements.

Key responsibilities include contributing to the completion of specific programs and projects, usually under the direction of a project leader. The candidate must have an excellent understanding of applicable standards, regulations, and industry practices, along with strong auditing skills. Working under general direction, the candidate will independently determine and develop approaches to solutions, maintaining frequent inter-organization contacts to achieve stated objectives.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

Quality Systems (QS) Activities:

• Lead QS activities, ensuring regulatory compliance for all aspects of QS processes.
• Lead internal audit programs and preparation of Quality Management Review materials.
• Plan and schedule QMS activities, ensuring timely completion of action items.
• Lead third-party quality audits, manage documentation, and close the loop with external auditors.
• Author, review, and provide input for QS documents to ensure compliance with QSR, ISO, and EN requirements.
• Understand post-market surveillance and complaint handling processes.
• Provide QS knowledge and administer appropriate training as needed.
• Review and improve existing quality procedure workflows, identifying areas for efficiency enhancement.
• Independently author quality investigation reports with appropriate corrective and preventive actions.
• Support internal and external regulatory inspections and audits.
• Train, develop, and provide relevant technical guidance to cross-functional team members.
  

Data Analysis:

• Collect, clean, and analyze data from various sources to identify trends and insights for Quality systems enhancements.
• Develop and implement data digitization processes to streamline Quality operations.
• Create and maintain dashboards and reports to effectively visualize data and communicate findings to stakeholders.
• Collaborate with cross-functional teams to develop innovative solutions based on data analysis.
• Provide actionable recommendations to improve business processes and drive strategic initiatives.
• Ensure data accuracy and integrity by implementing best practices in data management.

Education and Experience:

Education:

• Bachelor’s degree in engineering or related discipline

Experience:

• Minimum 4 to 6 years of professional experience
  

Knowledge and Skills:

• Good working knowledge and auditing experience of medical device regulations and practices (ISO13485, FDA, QSR, etc.)
• Fair understanding of QA principles, concepts, industry practices and standards. General knowledge of related technical disciplines
• Proven experience in digitizing processes and developing innovative solutions.
• Strong analytical skills with the ability to interpret complex data sets.
• Proficiency in data visualization tools (e.g., Tableau, Power BI) and statistical software (e.g., Minitab, R, Python).
• Excellent communication skills to present findings and recommendations effectively.
• Experience in the medical device industry is a plus.
• Ability to work independently and collaboratively in a fast-paced environment.

Additional Skills (Not essential but will be an advantage):

• Certified as a ISO13485 Lead Auditor
• Trained on 21CFR 820 requirements and ISO14971.

Required Skills

Optional Skills

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Primary Work LocationIND Bengaluru - Technology Campus Additional Locations Work Shift