Sr. Quality Engineer - Design Quality

POSITION SUMMARY

The Senior Quality Engineer – Design Quality will be responsible for ensuring the quality and compliance of both new product development and sustaining engineering projects in the medical device/pharmaceutical combination product industry. The ideal candidate shall have experience in one or more of the following areas within the medical device industry: orthopedic hardware, software as a medical device, and/or drug delivery systems.

This role involves partnering with cross-functional teams to ensure that design processes and outputs meet all applicable regulatory requirements, including but not limited to FDA 21 CFR Part 820, ISO 13485, and ISO 14971. The Senior Quality Engineer will also play a critical role in risk management, design verification and validation (V&V), and continuous improvement initiatives.  

RESPONSIBILITIES

Key responsibilities of the position include but are not limited to the following. Other duties may be assigned based on business needs:

Design Quality Assurance:

o   Provide quality engineering support throughout the entire product development lifecycle, from concept through design transfer and commercialization.

o   Ensure that all design control activities are conducted in compliance with regulatory requirements and company standards.

o   Review and approve design inputs, design outputs, design verification and validation plans/reports, and design transfer activities.

o   Participate in design reviews, ensuring that design risks are identified, assessed, and mitigated appropriately.

o   Provide input on product and process development to ensure manufacturability, reliability, and compliance with quality standards.

Risk Management:

o   Lead and facilitate risk management activities, including the creation and maintenance of risk management files in accordance with ISO 14971.

o   Conduct Failure Mode and Effects Analysis (FMEA) and other risk assessment tools to identify potential risks and develop mitigation strategies.

o   Ensure that risk management activities are integrated into the design control process and are continuously monitored throughout the product lifecycle.

Design Verification and Validation (V&V):

o   In collaboration with R&D, develop and review design verification and validation protocols and associated reports to ensure that products meet defined requirements and specifications.

o   Work closely with R&D, manufacturing, and other teams to ensure that V&V activities are conducted in compliance with regulatory requirements.

o   Review analytical methods, processes, and equipment to ensure that testing methods are accurate, reliable, and suitable for their intended purpose.

o   Contribute to continuous improvement efforts by identifying areas for enhancing testing processes, methodologies, and tools.

o   Analyze V&V data to ensure that products are safe, effective, and meet customer and regulatory expectations.

Sustaining Engineering:

o   Provide quality engineering support for sustaining engineering activities, including product changes, process improvements, and design modifications.

o   Ensure that changes to existing products are evaluated for impact on product quality and compliance, and that appropriate change controls are implemented.

o   Support post-market activities, including complaint investigation, root cause analysis, and implementation of corrective and preventive actions (CAPAs).

Continuous Improvement:

o   Identify and implement opportunities for continuous improvement in design quality processes and practices.

o   Participate in cross-functional teams to drive quality improvements and operational efficiencies.

o   Monitor and analyze quality metrics related to design and development activities, and report findings to management.

Regulatory Compliance and Audits:

o   Support regulatory inspections and external audits related to design and development activities.

o   Ensure that design history files (DHF) and technical documentation are complete, accurate, and compliant with applicable regulations.

o   Collaborate with regulatory affairs to ensure that product submissions meet regulatory requirements.

QUALIFICATIONS

·        Bachelor’s degree in Engineering, Life Sciences, or a related field.

·        5+ years of experience in quality engineering within the medical device, pharmaceutical, or combination product industry, with a focus on design quality.

·        In-depth knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other relevant standards and regulations.

·        Experience with design control, risk management, and V&V activities.

·        Strong problem-solving skills, with experience in root cause analysis and CAPA.

·        Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams.

·        Proficiency in quality tools and methodologies, such as FMEA, Six Sigma, or Lean.

Preferred Qualifications:

·        Master’s degree in Engineering or related field.

·        Certified Quality Engineer (CQE) or Certified Six Sigma Black Belt (CSSBB).

·        Experience with combination products and drug-device regulatory requirements.

·        Experience with eQMS software and design software (e.g., CAD).

·        Working knowledge of IEC 62304 and/or IEC 60601 requirements.

COMPENSATION AND BENEFITS:

Osteal Therapeutics offers a competitive compensation and benefits package, including salary, bonus potential, equity ownership, and a comprehensive benefits package.

We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.