ATEX Technologies, Inc Hiring for Quality Engineer – Medical Devices Job at Pinebluff, NC Full Time

Quality Engineer – Medical Devices

ATEX Technologies, Inc., an established implantable medical device manufacturer located in Pinebluff, NC, is seeking a detail oriented and multi-tasking quality engineer with an analytical aptitude. This individual is a self-starting achiever, who wants to make a difference. This individual needs to excel working independently or in a team environment and be comfortable in a fast-paced setting. This position will ensure performance and quality of finished products, components, and raw materials, and ensure conformance to established company and regulatory standards.

Position Responsibilities

• BS in Engineering, Technology, Science, Textiles, Biomedical or related field of study
• Minimum of 2 years of Quality experience in fields on design, validation, and verification; has worked through the entire life cycle.
• Integrated technology and risk management processes via phased approach based on regulatory compliance, business priority and market release timing.
• Wrote design matric, design verification protocols and test methods to perform Investigational Device Qualification and batch testing
• Managed, updated and monitored Risk Management deliverables
• Provide Quality Assurance support for the development and transfer to manufacturing of medical components or assemblies.
• Ability to work with team to gather information to develop a validation plan for new product development and write supporting Measurement System Analysis, Validation Protocols and Reports.
• Develop internal specifications based on customer-specific requirements as per customer’s documentation.
• Conduct data collection, data analysis, and trending to assist development and manufacturing with process improvements.
• Provide technical guidance and measurement methodologies in addition to assisting in problem solving.
• Follow an established stage gate process to ensure proper controls, operator instructions and quality tools used to verify customer’s products at all product life cycle phases.
• Assist and/or lead in thorough investigations for root cause analysis and effective corrective and/or preventative action
• Expertise to effectively communicate within all levels of the organization.
• Must possess a strong sense of urgency, teamwork, keen attention to detail, ability to plan, organize and work well under pressure.

Preferred Requirements

• Worked on Class II Urinary and Class III cardiac devices.
• Knowledge of regulated industry such as ISO: 13485 or ISO-9001 a plus
• Knowledge of SPC, FMEA, and Control Plan development a plus
• Design of Experiments (DOE) experience a plus
• Knowledge and/or working experience with a Document Management System (DMS)
• Knowledge of Minitab or other statistical software

If you are an experienced quality professional looking to make a large impact within an organization this may be the opportunity for you.

Benefits

• Medical
• Dental
• Vision
• Basic Life and AD&D
• 401(k)
• Voluntary Life and AD&D
• Short Term Disability
• Long Term Disability
• Wellness and Self Care

Additional Benefits

• Tuition Reimbursement
• Community Involvement
• Opportunities
• Family Culture

Drug Screening, Post-offer Physical Examination & Criminal Background Search Required – EOE and Drug-Free Workplace.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Pinebluff, NC 28373: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Do you have knowledge of Minitab or other statistical software?
• Have you worked on Class II Urinary and Class III cardiac devices?
• Do you have knowledge of regulated industry such as ISO: 13485 or ISO: 9001?
• Do you have a minimum of 2 years of Quality experience in fields on design, validation and verification?

Work Location: One location