Job Summary

Sr. Engineer Quality Systems supports and executes the effective development implementation and continuity of the Quality Management System (QMS) at a site and business unit level ensuring compliance with ISO 13485 EUMDR GxP and other regulatory requirements. This role encompasses responsibilities such as supporting and managing the CAPA program(s) non-conformance process(es) management review(s) audit(s) document control etc. Sr. Engineer Quality Systems collaborates with business leaders to create and maintain efficient quality system programs driving change management and continuous improvement initiatives. Provide training on quality best practices and utilize ISO 14971 risk management techniques to ensure alignment with quality requirements. As a key communicator this position demands excellent written and verbal skills to engage confidently across organizational levels. The role requires meticulous documentation practices adherence to good manufacturing practices and active participation in continuous improvement projects ensuring a safe work environment and compliance with company policies and regulatory standards. This is an onsite role based in Scottsdale AZ.

Essential Duties and Responsibilities

• Contribute to the enhancement of local site and business unit level QMS to ensure strict compliance with FDA 21CFR Part 820 ISO 13485 EUMDR GxP and relevant regulatory requirements.
• Collaborate with departments and sister-sites to set and maintain quality objectives metrics and programs.
• Coordinate and prepare critical information for Management Reviews and safeguard key performance metrics (KPIs) within compliance frameworks.
• Manage the non-conformance system to guarantee comprehensive documentation and resolution of incidents.
• Support internal and external audits by regulatory bodies and clients ensuring compliance with established quality standards.
• Drive effective change management processes at a site and business unit level assessing product/process modifications against quality requirements.
• Train staff to procedures and quality best practices fostering an organization-wide quality-centric culture.
• Utilize ISO 14971 risk management techniques to mitigate risks in product development and manufacturing processes.
• Develop and uphold robust procedures for quality system elements per ISO 13485.
• Identify and propose process improvements to enhance quality and operational efficiency.
• Oversee the Corrective and Preventive Action (CAPA) process ensuring thorough investigation and resolution through the CAPA Review Board (CRB).
• Facilitate root cause analysis implementing CAPA to address quality issues and support continuous improvement initiatives.
• Maintain a high level of scrutiny in reviewing and approving CAPA investigations and extensions.
• Provide detailed reports and insights on QMS performance to senior management.
• Align activities with regulatory guidelines such as FDA 21CFR Part 820 ISO 13485 GxPs and ISO 14971.
• Adhere to all regulations policies and safety protocols consistently.
• Maintain punctuality and reliable attendance adhering to a customer service-oriented approach.
• Keep a clean orderly and safe working environment.

Basic Qualifications

• Education: Bachelors Degree in Engineering or Science or equivalent experience required
• Work Experience: 5-8yrs of experience in a Quality Management System (QMS) or Quality Assurance or Quality Engineering role(s) specifically within medical devices is essential (medical device manufacturing preferred).
• Proven track record in handling Quality System Procedure(s) CAPA non-conformance and audits as part of a QMS. Proficient knowledge of ISO 13485 ISO 14971 FDA 21CFR Part 820 and EUMDR.
• Regulatory and QMS Knowledge: Comprehensive understanding of ISO 13485 ISO 14971 FDA 21CFR Part 820 and EUMDR. Comprehensive understanding of ISO 13485 ISO 14971 FDA 21CFR Part 820 and EUMDR.
• Skills and Competencies: Strong analytical and problem-solving skills particularly in non-conformance CAPA and root-cause analysis. Excellent organizational skills and the ability to communicate effectively at various levels of the organization. Proficiency in working within a team-oriented environment with strong interpersonal capabilities.

Preferred Knowledge Skills and Abilities

• Technical Proficiency: Demonstrated expertise in computer skills and familiarity with quality-related software and tools including EDMS and SAP.
• Deadline & Project Management: Proven ability to efficiently meet deadlines in a fast-paced changing environment.
• Problem-Solving Expertise: Strong problem-solving skills with knowledge of Lean Six Sigma methodologies being advantageous.
• Root Cause Analysis: Proficient in Root Cause Analysis methodologies such as A3 5 Whys 6Ms 8Ds and DMAIC.
• Regulatory Knowledge: In-depth understanding of Medical Device Regulatory Requirements and Standards including 21 CFR Part 820 EU/MDR ISO 13485 ISO 14791 GMPs and GDP.
• Analytical Skills: Strong data analysis skills with knowledge of statistical requirements for sampling plans (application of Minitab statistical software preferred).
• Organizational Skills: Highly organized detail-oriented and self-motivated with project management expertise.
• Communication Skills: Experienced in report writing with clear and effective communication and experience working with manufacturing operations. Ability to communicate with and to multiple levels and positions within the organization.
• Validation Expertise: Skilled in validation processes and experienced with manufacturing operations.
• Collaborative & Independent Work: Ability to work effectively both individually and as part of a team with the capability to engage and leverage others to accomplish projects.
• Procedural Awareness: Ability to develop understand and adhere to all relevant standard operating procedures as per company policies and regulations related to this role

LI-NJ1

LI-Onsite

License and Certifications

Certification in Quality Engineering (CQE) or as a Certified Quality Auditor (CQA) is preferred.

Travel Requirements

Physical Requirements