Staff Quality Engineer, Post Market Quality

Provide quality engineering leadership and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.

• Work closely with operations and the business functions to ensure quality performance of product and processes. (SGS).
• Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues. (DD).
• Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.
• Initiates and leads in the development and improvement of the manufacturing processes for existing products. (SGS).
• Oversight and leads investigations during concession management. (SGS).
• Review and approval of change management activities, challenges effectiveness and drives strong review.
• Interpret KPI trends, drive continuous improvement process.
• Advocate of Human Factor practices, proficiency in the science of identification of mitigation.
• Subject matter expert in risk management practices and concepts.
• Develop and provide input by identifying opportunities and weaknesses.
• Proficiency in and provides technical direction in optimization of inspection methods and sampling.
• High proficiency in statistical methods and application.
• Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation.
• Aids in the development of validation strategies for existing products. (SGS).
• Support manufacturing transfers to other plants/facilities, leading quality activities. (SGS).
• Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
• Coach and mentor others in quality topics and activities.

• BS in a science, engineering or related discipline.
• MS, CQE, or CRE preferred.
• Six Sigma Green or Black belt preferred.
• Minimum of 5 years experience preferred.

• Previous industry experience required.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
• Understanding of US and International Medical Device Regulations.
• Familiarity with ISO 13485, GDP, GMP required.
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
• Ability to represent Quality function within and across project teams.
• Strong interpersonal skills, written, oral communication and negotiations skills.
• Strong in critical thinking and ""outside the box"" thinking.
• Highly developed problem solving skills. Strong analytical skills.
• Demonstrated ability to successfully manage and complete projects in a matrix organization.
• Demonstrated ability to work independently and as part of cross-functional teams.
• Experience in working in a compliance risk situation.
• Computer literacy.
• Some travel may be required.