What are the responsibilities and job description for the Senior Quality Engineer position at Comrise?
Overview
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 regulations and standards.
Responsibilities
Key areas of responsibility:
• Work closely with operations and the business functions to ensure quality performance of product and processes.
• Work closely with cross-functional teams to address top quality issues.
• Review of change management activities.
• Proficient understanding of risk management practices and concepts.
• Develop and provide input by identifying opportunities and weaknesses.
• Proficient in statistical methods and application.
• Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
• Support manufacturing transfers to other plants/facilities, leading quality activities.
• Coach and mentor others in quality topics and activities.
Qualifications
Education / work experience:
• BS in a science, engineering, or related discipline.
• MS, CQE, or CRE 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.
Salary : $65 - $70
