Senior Quality Engineer

Oxford Global Resources; Gary (IN); On-site; USD 79,000 - 103,000; Full time

Job summary

Oxford Global Resources is seeking a Senior Quality Engineer focused on software quality assurance within the medical device space. You will develop and implement quality plans across the product lifecycle, emphasizing software validation, design controls, and compliance.

You will oversee risk management, perform independent assessments, and lead root cause analysis to ensure products meet customer requirements and regulatory standards.

Qualifications

• Engineering degree or equivalent experience in medical device industry.
• ASQ certified Quality Engineer.
• Working knowledge of C++, Java, Python, or other managed programming language.
• Understanding of quality philosophies, principles, systems, methods, tools, standards, and ethics.

Responsibilities

• Ensure that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design with an emphasis on software validation and design controls.
• Validate key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
• Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle with an emphasis on software
• Perform independent technical assessment on product quality performance and post-market product quality analysis
• Lead quality related problem solving and root cause analysis during design and manufacturing
• Act as a single point of contact (person assigned to project team) responsible to ensure that software based design meets quality and compliance standards for every milestone
• Function as a local subject matter expert on software validation techniques and management of electronic records and signatures
• Provide leadership and oversight to ensure Quality Management System Compliance

Skills

C++

Java

Python

ASQ Certification

Quality Assurance

Education

Engineering degree

Job description

Summary

A Senior Quality Engineer is responsible for developing and implementing systems to ensure products or services are designed and produced to meet or exceed customer requirements and expectations; participates in the cross-functional change management process to assure the products or services continue to meet customer requirements; provides independent oversight and review of the project deliverables throughout the product lifecycle; and provides leadership and is responsible and accountable to the organization for own decisions and actions, while also holding others accountable for the same. This position will have a focus on software based quality assurance both in design and manufacturing.

Project Details

• Ensure that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design with an emphasis on software validation and design controls
• Validate key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle with an emphasis on software
• Perform independent technical assessment on product quality performance and post-market product quality analysis
• Lead quality related problem solving and root cause analysis during design and manufacturing
• Act as a single point of contact (person assigned to project team) responsible to ensure that software based design meets quality and compliance standards for every milestone
• Function as a local subject matter expert on software validation techniques and management of electronic records and signatures
• Provide leadership and oversight to ensure Quality Management System Compliance

Job Experience

• Engineering Degree or equivalent experience in medical device industry
• ASQ certified Quality Engineer
• Working knowledge of C++, Java, Python, or other managed programming language
• Have an understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics
• Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements
• Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving

Hourly Rate: 57-75

Oxford is an Equal Employment Opportunity Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

Oxford provides supplemental medical (we do not offer major medical), dental, vision, life, and disability benefit plans along with a 401(k) Retirement Savings Plan.

Paid holidays based on eligibility and paid sick leave for applicable jurisdiction, as required.

Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email [e-mail]. We will make a determination on your request for reasonable accommodation on a case‑basis.