Senior Quality Engineer
Location: Woburn MA
Advertising Date: Fri 27 August 2021
Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer 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. We are a fast growing, dynamic organization.
Primary focus of this role will be to provide Quality Engineering support in the execution of design control and risk management deliverables associated with new and existing products to meet global medical device regulations.
The role also provides Quality Engineering support for manufacturing and supplier related activities associated with new and existing products.
- Serve as Quality Engineering representative ensuring that design and manufacturing related activities are completed and comply with global medical device regulations (e.g., FDA, EU, etc.) and Sirtex Quality System requirements.
- Generate and ensure compliant completion of Quality deliverables such as Design Reviews, Engineering Change Orders, Design & Development Plan, Risk Management, User Needs, Design Input Requirements, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, Packaging, Labeling, Statistical sampling plans, etc.,
- Provide Quality Engineering support in as part of supplier qualification, audit, ongoing monitoring and supplier improvement activities.
- Develop and deploy Quality System related processes, tools, training, and metrics to enabling Sirtex to meet business needs and comply and global medical device regulations
- Serve as Subject Matter Expert on Design Controls and Risk Management medical device regulatory requirements
- Lead CAPA, post market surveillance and other quality improvement efforts
- Provide key quality trending information and data for use in periodic reviews
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
Educational Prerequisites and Skill Requirements
- Minimum of 5 years Quality Engineering design controls/risk management experience within Medical Device industry for companies with greater than $1bn USD annual revenue
- BS. in STEM (Science, Technology, Engineering, Mathematics)
- Demonstrable competency with the 21 CFR, 820, Medical Device Directive, EN ISO 13485, and EN ISO 14971, particularly with respect to product design & development and product risk management.
- Familiarity with the EU MDR regulation and Post Market Surveillance requirements
- Strong communication and presentation skills.
- Competent in Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
- Ability to prioritize, focus, collaborate, and work effectively in a fast paced and dynamic cross functional environment
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
How to Apply
To apply, please email your cover letter and resumé to Human Resources at email@example.com
Sirtex is an Equal Opportunity/Affirmative Action Employer including Disabled/Vets