POSITION TITLE: Sr. Quality Engineer
POSITION OVERVIEW: This role is responsible for investigating, planning, and implementing improvements or additions to current products and manufacturing processes to enhance safety, quality, and productivity, resulting in a more efficient production of high-quality products. Key responsibilities include ensuring compliance with quality policies, responding to customer complaints, performing audits, developing test methods, and writing procedures for material characterization.
Job Details:
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Provides focused quality engineering support and takes responsibility for the timely and effective coordination or execution of assigned development project activities.
- Establishes effective corrective action plans. Leads the implementation of quality assurance plans, process controls, and CAPA systems to meet or exceed internal and external requirements.
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Applies sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Reviews and approves product and process qualifications, validations, and other change control-related documentation.
- Develops product/process assurance plans, including all required elements. Identifies and implements effective process control systems to support product development, qualification, and on-going manufacturing to meet or exceed internal and external requirements.
- Generates internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
- Participates in Product Review Boards. Identifies non-conformance trends and develops technical investigation plans. Investigates and analyzes customer/internal complaints.
- Performs analytical measurements and experiments to qualify or resolve product and process issues.
Knowledge, Skills, and Abilities:
- Strong verbal and written communication skills.
- Excellent organizational and time management skills essential for project work.
- Certification as a CQA, CQE, or CQM, and membership in ASQ preferred.
- Proficiency in computer skills.
- Strong writing, mathematics, and statistics skills.
Background and Experience:
- Requires a minimum of a 4-year degree in engineering, life sciences, or a similar discipline.
- Requires eight years of increasing responsibility in a relevant role.
- Experience in a medical device quality assurance environment preferred.
- Auditor experience is a plus.