Position Summary:

With a high degree of autonomy, person will perform quality work of a broad nature to achieve successful outcomes of departmental and company objectives. 

The Quality Engineer will contribute to ensure that production and process control activities are conducted in compliance with the company quality management system and the international regulations governing medical device manufacturing and distribution.

Evaluates situations of non-conforming products, collects and analyses data to propose product disposition and CAPA's to address quality issues.  This position also analyzes product complaint returns and determines actions required to prevent recurrence or communicates the information to the manufacturer or creates process improvements.

General Responsibilities:

Supports Quality Management for executing the quality engineering activities related to the design and manufacture of the products in compliance with the Quality Management System requirements and the regulations of the countries where the franchise distributes and sells products.

• Collect and critically analyze data and take disposition decisions on nonconforming products identified in production.
• Lead proper investigation to identify the causes of components / product failures (nonconforming products from production and complaints)
• Generate the evaluation of the risk posed by the observed NC on products already distributed (Health Hazard Evaluation) to help management determine if Stop Shipment and/or Field Action is initiated.
• Lead CAPA projects and trend data to identify opportunities for future CAPA.
• Whenever applicable support external manufacturers of semi-finished and finished products in the management of any detected nonconformities.
• May notify suppliers of any non-conformance related to purchased material and evaluate corrective actions consistency versus internal controls.
• Establishes product quality control inspections/plans
• Reviews process validation planning, protocols and reports
• Perform preliminary review of the change impact assessment to confirm that quality requirements are met
• Establish and maintain Risk Management files
• Collaborates in the investigations into the cause of V&V failures
• Identify opportunities for quality improvements in the production area and lead improvement plans
• Daily management of the assigned complaint handling activities.
• Customer-related processes involving use of the device.
• Complaint evaluations and investigations.
• Provides support for timely analysis to meet Customer Quality complaint and MDR reporting quality metrics.
• Leads effective meetings, conducts presentations, establishes quality records.
• Develops effective relationships with internal personnel and external stakeholders to assist customers and drive the resolution of customer complaints

Skills and Experience:

• Minimum related work experience of 1-3 years in Class II/III medical device manufacturing or related regulatory industry.

•Knowledge of regulatory requirements (e.g., FDA, ISO 13485) as required for the position.

• Experience with MDSAP and Medical Device Requirements is a plus

• Must have proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning

• Ability to analyze and problem-solve with CAPA experience

• Ability to work within a changing environment.

• Ability to work with a wide variety of personnel on all levels and utilize constructive confrontation

• ASQ Certified Quality Engineer or other ASQ Certifications is a plus.

• Excellent communication (written and verbal) and presentation skills.

• Able to communicate across functional lines.

• Sitting 60-80%, standing & walking 20-40%

• Repetitive work on computer 80%

• Oral and written comprehension

• Must be able to work in a clean room environment and tolerate chemical odors.

• Must be able to work in a lab environment and tolerate the smell and sight of blood.

• Must be willing to take on related duties as required in support of company and departmental objectives.

Education:

Bachelor’s Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, and Biology)

Pay Transparency: $85,000-$95,000 salary + annual bonus incentive.

Travel Requirements:

Occasional travel may be required.