Quality Systems Engineer – Woburn MA
Quality Systems Engineer – Woburn MA
Sirtex Medical is a global healthcare business with offices in the US, Australia, Germany and Singapore, working to improve outcomes in people with cancer.
Our current lead product is a targeted radiation therapy for liver tumors called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries.
Our mission is to improve the quality and longevity of patient’s lives by providing interventional oncology solutions.
Sirtex requires various regulatory approvals to manufacture and supply its products in order to operate commercially. A formal Quality Management System is an integral part of achieving and maintaining required certifications and approvals, and ensures consistent, compliant operation of the company.
The Quality Engineer supports the management of the Sirtex QMS in accordance with ISO13485 and applicable regulatory requirements. The main areas of the role include but not limited to, quality system management, design control, complaint handling and investigation, Corrective and Preventive Actions (CAPA), supplier management, risk management and internal audits.
- Support Design and Development projects with design control expertise, assist with compilation of Design History File and content audits
- Actively learn, and apply knowledge of Quality Systems, Design Controls, Risk Management, Statistics and Design for Reliability to positively influence development efforts, quality systems and processes, and ongoing contract manufacturing support as needed
- Ensure products are developed and manufactured in accordance with applicable industry standards, applicable regulatory requirements, customer requirements, and product specifications.
- Support and/or lead product test development activities including method development, protocol and report writing, and sourcing of equipment our outside vendors
- Lead and participate in the generation, review and update of product, process and design Risk Management files and other risk management activities
- Support the complaint handling process, including the investigation of root cause, trending and analysis of complaints
- Support the coordination of Corrective and Preventive Actions process inclduing the investigation of root cause and implementation of CAPA
- Support the maintenance of Quality System databases, and reporting of statistical analysis and relevant data trending
- Support Sirtex global manufacturing facilities in the establishment and maintenance of IQ/OQ/PQ and process validation
- Apply statistical techniques to determine sample size for testing, to analyze data, to determine process capability, to complete Measurement Systems Analyses, etc. (i.e. T-test, Tolerance Analysis, Bayes Success Run/Weibel analysis, Capability Analysis, Design of Experiments/ANOVA)
- Support verification and validation activities in terms of plans and execution
- Coordinate and conduct internal quality system audit in accordance with ISO13485 and all applicable regulatory requirements
- Maintain supplier management by conducting regular supplier audits, and maintaining supplier files and certification
- Assist in the management of changes to Sirtex QMS in response to external regulatory and standards updates, CAPA actions or audit findings
- Assist the Global Quality Assurance Director in general Quality Systems tasks, as required
- Undergo all formal Training Events as may be Directed from time-to-time
- Observe and Comply with all Sirtex Corporate Policies
- Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements.
- Work within, and ensure adherence to Health, Safety and Environment Management System procedures, instructions and other requirements.
Educational Prerequisites & Skill Requirements:
- 3- 5-years experience in medical devices, pharmaceutical or other similar highly regulated industries
- Bachelor’s Degree in Engineering, Science, Technical or related field
- Knowledge of Quality Management System, regulatory requirements, ISO13485, EU MDR, and MDSAP
- Experience with applying Risk Management tools (Hazard Analysis, Risk Analysis, FMEA’s, Fault Tree Analysis, Use Error Analysis, etc.)
- Experience applying root cause analysis tools (e.g. Fishbone charts, 5 Why’s, DMAIC, etc.)
- Experience with statistical analysis and modelling, and the use of related software suites (e.g. SAS, Minitab, Statistica, Statgraphics, etc.)
- Experience writing or guiding product requirements documents and test methods, protocols and reports
- Prior experience with SAP preferred but not essential
- Understanding of Quality principles and ability to administer and work with Quality Systems
- Internal Auditor Certification preferred but not essential
- Excellent learning capability, strong analytical skills, communication skills and attention to detail
- Training in relevant procedures, work instructions and record requirements
What you can expect from Sirtex
If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate:
- Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives
- A working culture of respect, diversity and performance to help facilitate an inclusive culture
- Attractive compensation and benefit packages which are practical, robust, fair and equitable
- A place to grow through career development and training opportunities
- Challenging work to continue to develop new and better ways to improve clinical outcomes for oncology treatment around the world.
To apply, please click the apply button or email your cover letter and resume to Human Resources at email@example.com
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