Quality Assurance Engineer

Company Description

Job Description

• Analyzes production limitations and problems and facilitates root cause analysis.
• Analyzes data to bring conclusions to production and quality management.
• Reviews change orders for product releases/updates and production material and process changes.
• Conducts and documents internal non-conformances and customer complaint investigations.
• Formulates or assists in formulating quality standards, policies, programs, plans, procedures, and practices.
• Assesses and approves product and process validation activities.
• Performs such individual assignments as supervisors and superiors may direct.
• Ensures adequate and continuous controls are exercised over all assigned activities affecting quality.
• Establishes and maintains effective work relationships.
• Maintains the professional competence, knowledge and skill necessary for the satisfactory performance of all assigned responsibilities.
• Facilitates the completion of Risk Analysis documentation for new and existing products/processes.
• Organize and conduct internal supplier audits.
• Initiates and manages Corrective/Preventative actions based on data review and input from outside sources.
• Serves as quality contact during customer and notified body audits.

Qualifications

• Must have a Bachelor's degree in an engineering or scientific discipline and a minimum of 3 years quality assurance experience.
• Able to read and understand engineering design drawings, technical plans and reports.
• Possess knowledge and hands-on experience with ISO quality system standards (ISO 9001, 13485) and FDA 21 CFR 820. Experience with other quality system standards relating to automotive, aerospace or other related industries will be considered.
• Auditing education and experience.
• Ability to work effectively with various work groups to assure conformance to quality and regulatory requirements, internal processes, and policies.
• Ability to prioritize tasks in a deadline driven environment.
• Strong written and verbal communication and organizational skills.
• Certification in Quality (CQE, CSSBB, CQA) a plus.
• Ability to travel <10% as job requires.

Additional Information

• Diverse portfolio of exciting and innovative design projects
• Tremendous opportunities for professional growth and advancement
• Commitment to sustainable design
• Competitive Compensation
• Excellent Benefit Package (medical, dental, vision insurance, paid vacation time, paid sick time, disability insurance, 401k, tuition reimbursement and much more)
• Solid Stable Company
• Drug free workplace.