The client is an industry-leading innovator, manufacturer and supplier of medical technologies and devices, with headquarters in the United States, Canada and the Netherlands. They have grown significantly over the past several years and continue to invest in new technologies, companies and regions. They take great pride in supporting doctors, nurses, hospitals, clinics, academic institutions and patients with treatment and diagnostic innovations. They are focused on educating healthcare providers and their patients on the latest solutions in Urological and Gastrointestinal health.

Summary:
The client is currently searching for a Quality Engineer to join their team in Westborough, Massachusetts. Plans, coordinates, and directs Quality Engineering programs and functions to ensure that the production of product is in compliance with the Quality Systems, of the client and its subsidiaries, as well as FDA Quality System Regulation, ISO 13485, European Medical Device Directives, Canadian Medical Device Regulations, and other applicable laws and regulations. Perform specific functions within the Quality Assurance department, including complaint handling, corrective and preventative action, supplier performance, document control, reporting and analysis on product and processes affecting product to ensure products are designed and manufactured to predetermined specifications.

Responsibilities:

• Provide quality engineering support for quality, manufacturing, design & development documentation and other product related disciplines
• Apply statistical techniques and trending to monitor products, processes and controlled work environments to identify potential corrective or preventive actions
• Specify, qualify and monitor equipment used in manufacturing processes, inspection, testing, and controlled work environments
• Monitor facility and equipment calibration and maintenance program
• Perform and document risk analysis and make decisions based on risk management principles
• Perform and document investigations related to products, processes and quality systems
• Initiate, plan, perform and monitor corrective and preventive actions
• Develop, plan and perform product, process monitoring & measurement activities
• Evaluate proposed process/product changes to assure continued safety and quality
• Recommend and implement process and product changes/improvements
• Develop verification/validation protocols and reports and perform the necessary experimentation
• Review and approve proposed change orders, deviations and nonconforming material records to determine the effect of the changes on materials, products and processes
• Validate manufacturing processes, test methods, and quality processes as required
• Assist in the design/development activities for new or modified products and processes
• Collaborate and support design team personnel in the development of new or changed products, utilizing engineering skills
• Conduct internal quality system audits, as necessary
• Evaluate customer and product related communications/complaints
• Handling of returned goods including complaint devices that may be potentially contaminated by patients.
• Maintain a thorough knowledge of current QSR and ISO requirements as they apply to the medical device industry
• Perform other related duties or special assignments as specified by supervisor

Qualifications:

• Bachelors' degree in an engineering or related scientific field
• 3-5 years' experience working in a Quality capacity, preferably in the medical device industry
• Must possess the ability to write clear, concise and effective reports and procedures, learn quickly with guidance and training and work with minimal direct supervision
• Computer literacy with experience in spreadsheet, database and word-processing applications
• Processing and product evaluation experience Knowledgeable of QSR and ISO requirements
• Must be capable of establishing and maintaining an effective working relationship with manufacturing and technical personnel at all level.
• Knowledge of statistical methods and the applications thereof

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.