Quality Engineer

About the role

The Quality Engineer serves as a key quality assurance resource, providing hands-on support to ensure ongoing product manufacturing aligns with established quality and regulatory standards. This position works very closely with the Manufacturing Engineering team, is directly involved in day-to-day production processes, and can act as a backup for all quality-related responsibilities.

Responsibilities

• Identify and assist with process validation activities.
• Support projects related to manufacturing plant layout/process to ensure efficient and timely completion.
• Manage multiple projects in various stages of production, including, process improvements, quality inspections, and quarantine and inventory control.
• Lead risk management activities such as verification of risk mitigation implementation in products and processes (PFMEA).
• Absorb design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.
• Inspect product including labeling and documentation for release of finished goods.
• Absorb assistance with Operations and Engineering to ensure that all production employees are familiar with, trained on, and follow all manufacturing procedures related to their jobs.
• Ensure that changes to procedures are reviewed, approved and validated prior to implementation.
• Oversee creation and review of documentation for nonconforming products.
• Provide quality engineering support and expertise in the investigation of nonconformances and CAPAs.
• Work with Engineering department ensuring that engineering change orders affecting production related changes are reviewed.
• Keep management informed of significant issues identified during production-related quality activities as well as actions being taken to improve and correct the situation.
• Oversee revisions and updates to quality procedures, standardized work instructions.
• Participate in supplier management activities. Identify supplier quality issues and report to management in timely manner.
• Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA etc.).
• Other duties as assigned.

Requirements

• Must have a four-year engineering degree.
• Bachelor’s or Master’s Degree in a technical area.
• Minimum of 5–10 years related experience.
• Minimum of 4 years of work experience in a Quality Engineering role within a manufacturing environment in the Medical Device preferred.
• ISO 13485 and GMP Experience.
• High proficiency in computer technology and systems operations.
• Strong knowledge of Microsoft Office applications.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.
• Auto CAD, Solid Works, ERP experience is a plus.
• Experience working under a microscope is a plus.

Qualifications

• Must have a four-year engineering degree.
• Must have a Bachelor’s or Master’s Degree in a technical area.
• Must have 5–10 years related experience.
• Must have 4 years of work experience in a Quality Engineering role within a manufacturing environment in the Medical Device.
• Must have ISO 13485 and GMP Experience.
• Must have high proficiency in computer technology and systems operations.
• Must have strong knowledge of Microsoft Office applications.
• Must have strong analytical and problem-solving skills.
• Must have excellent verbal and written communication skills.
• Must have Auto CAD, Solid Works, ERP experience.
• Must have experience working under a microscope.

Skills

• Quality Assurance
• Manufacturing Process Improvement
• Project Management
• Process Validation
• Risk Management
• Design Transfer
• Quality Control
• Documentation Management
• Supplier Management
• Nonconformance Investigation
• Engineering Change Orders
• Third Party Audits

Benefits

• Medical – 90% employer paid
• Dental – 100% employer paid
• Life Insurance, AD&D, STD & LTD Insurance – 100% employer paid
• Vision
• 401k Matching
• Paid Leave: Sick, Vacation and Holidays