Quality Engineer III

Spectrum Plastics Group•Tucson, AZ

1d•Onsite

About The Position

Serve as a senior-level Quality Engineer with leadership responsibilities in medical device QMS compliance, strategic quality initiatives, and cross-functional project execution. Drive continuous improvement in product quality, regulatory compliance, and risk management across the product lifecycle. Act as a subject matter expert (SME) in core QMS elements and global regulatory standards.

Requirements

Bachelor’s Degree in Engineering (Biomedical, Mechanical, Industrial, or related field); Master’s preferred.
5–8 years of experience in the medical device industry with increasing responsibility.
Expert knowledge of FDA QSR, ISO 13485:2016, ISO 14971, and global regulatory expectations.
Demonstrated experience leading audits, validation activities, and cross-functional quality initiatives.
Strong understanding of design controls, DHF/DMR/Tech Files, and quality planning for new product development.
Proficient in statistical analysis, RCA and corrective actions using problem solving (e.g., 8D, 5W), and other quality engineering tools.
Ability to communicate and influence across multiple levels of the organization.
Skilled in managing multiple priorities in a fast-paced, regulated environment.
Responsible for understanding and complying with all SPG and Dupont safety policies and procedures

Nice To Haves

Lean Six Sigma Black Belt certification.
ISO 13485 Lead Auditor certified
Regulatory compliance experience with FDA, EU MDR, and MDSAP.
Experience implementing or optimizing eQMS platforms.
Experience in team leadership, mentoring, or informal management roles.

Responsibilities

Lead large-scale or cross-functional quality projects involving product lifecycle management, validation, CAPA, audit readiness, risk management, or supplier quality improvement.
Act as a quality lead on new product development or design transfer projects, ensuring compliance with design control and risk management requirements.
Develop and implement risk management strategies in accordance with ISO 14971 and maintain risk files throughout product lifecycle.
Provide expert-level input on process validation and sterilization validation strategies, including complex or novel technologies.
Lead internal and supplier audits and actively support external audits (FDA, ISO, MDSAP) as quality system SME.
Drive standardization and continuous improvement in QMS elements such as CAPA, complaint handling, supplier management, and document control.
Serve as a mentor and technical resource for junior engineers and cross-functional stakeholders.
Use statistical tools (e.g., SPC, DOE, MSA) and Lean Six Sigma methodologies to identify trends, reduce defects, and improve product quality and process stability.
Develop and present quality performance reports to leadership; make data-driven recommendations for improvement.
Review and approve technical documentation including engineering change orders, validation protocols, inspection plans, and risk assessments.
Actively participate in Value Stream Teams as a functional member, engaged in improving first pass yield, scrap reduction, process improvements.
Stay abreast of changes in regulatory requirements and lead implementation of necessary updates to the QMS.
Performs all other duties as assigned
Uphold SPG and Dupont vision and core values