Quality Engineer

The Quality Assurance Engineer ensures compliance to existing procedures and regulations through document review, audits and facilitation of risk management, data trending and root cause analysis.

• Analyzes production limitations and problems and facilitates root cause analysis.
• Analyzes data to bring conclusion to production and quality management.
• Reviews change orders for product releases/updates and production material and process changes.
• Conducts and documents internal non-conformance and customer complaint investigations.
• Support in Medical Device reporting (MDRs), complaints, field corrective action (Recall) and management review meeting
• Effectively engage in project as the Quality Engineering resource.
• 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 and supplier audits.
• Initiates and manages Corrective/Preventative actions based on data review and input from outside sources and internal data analytics.
• Serves as quality contact during customer and notified body audits

• Able to read and understand engineering design drawings technical plans and reports.
• Possess knowledge and hands-on experience with ISO quality system standards ISO 13485, ISO 14971, and FDA 21 CFR 820.
• 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 deadline driven environment.
• Strong written and verbal communication and organizational skills

• Bachelor's Degree in Mechanical Engineering, Manufacturing Technology, Business, or related discipline from an accredited university.
• Minimum of 3 years of quality assurance experience.
• Certification in Quality (CQE CSSBB CQA) a plus.

• 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 time off, disability insurance, 401k, tuition reimbursement and much more).
• Solid Stable Company.
• Drug free workplace.