The Senior Engineer provides quality engineering support focused on continuous product and process improvement, ensuring compliance with regulations. Responsibilities include managing quality issues, conducting audits, and mentoring teams in quality practices while interfacing with cross-functional teams and regulatory agencies.
Work Flexibility: Hybrid or Onsite
Position summary
Provide quality engineering support 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. Ensure compliance to regulation and standards.
Key areas of responsibility
- Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
- Oversight of NC/CAPA, activist and mentor in problem-solving and root-causing activities.
- Review of change management activities.
- Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.
- Support execution and analysis of complaints and product field actions.
- Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
- Proficient understanding of risk management practices and concepts.
- Develop and provide input by identifying opportunities and weaknesses.
- Proficient in statistical methods and application.
- Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audit preparation building confidence and proficiency in interactions.
- 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.
Education / work experience
- BS in a science, engineering or related discipline.
- MS, CQE, or CRE preferred.
- Six Sigma Green or Black belt preferred.
- Minimum of 3 years experience preferred.
Knowledge / competencies
- Previous industry experience desired.
- 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 desired.
- 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 with 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.
Travel Percentage: 10%
Top Skills
Quality Assurance
Quality Control
Six Sigma
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