Location: Woburn MA
Posted Date: 03/12/2021
Sirtex Medical is a global life sciences company 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.
The Quality Manager will
- Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines to ensure lasting customer satisfaction.
- Ensures that a Quality Management System for Sirtex products business is implemented, maintained, and effective for product manufacturing, control, storage, and primary distribution processes in accordance with Quality System Directives, all applicable Quality Systems standards and regulations (i.e. FDA QSR, ISO 13485, ISO 14971, MDR, and Canadian SOR etc.)
- Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to determine responsibilities and solutions.
- Work with engineering regarding Risk Management activities (PFMEA's, Control Plans, CAPA etc.)
- Reviews, analyzes and reports on quality discrepancies related to process and product function systems and develops disposition and corrective actions for recurring discrepancies.
- May serve as liaison between the company and the various governmental agencies.
- Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications; works with Research and Development during new product development, and establishes key checkpoints for new products and processes.
- Lead internal and external audits by customers, notified bodies, and other regulatory organizations.
- Responsible for managing CAPA system.
- Responsible for managing Document Control functions and compliance
- Support the organization in documentation and performance of process validation, design verification/validation, and test method validation activities.
- Assists in and/or manages functional deliverables and ensures technical excellence for product or technical development.
- Provides guidance and approval regarding quality strategies and approaches.
- Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high-quality staff.
- Assists in and/or completes the development of budgets and monitors spending.
- Assists in identifying and developing department tools.
- Assists in and/or determines appropriate staff levels, schedules and resources. Works with project managers to understand priorities and plan resource and time allocation accordingly
- Maintains and enhances cross-functional team relationships.
- Works cross-functionally in identifying and resolving technical issues.
- Monitors and evaluates project and department progress and results. What we are looking for in you:
- BS in Mechanical, Electrical, Biomedical Engineering or related engineering degree
- Minimum of 10 years of Medical device engineering experience.
- Travel approximately 10-15% of the time
- In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
- Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366.
Educational Prerequisites and Skill Requirements
- MS or advanced degree
- 10+ years of medical device engineering experience or equivalent
- Relevant quality certifications (e.g., Lead Auditor, ASQ, etc.) preferred
- Strong communication and presentation skills.
- Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
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 email your cover letter and resume to Human Resources at firstname.lastname@example.org
Sirtex is an Equal Opportunity/Affirmative Action Employer including Disabled/Vets