Senior Quality Manager
ResponsibilitiesLocation Boston, MassachusettsUS Job ID JR-026336
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
Our dedicated team of about 14,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
If you are seeking a meaningful, impactful, and stimulating career, look no further.
The Sr Quality Manager is the leader for Quality activities at the Boston location for PerkinElmer. The individual is responsible for all Quality initiatives throughout the Boston site, including setting and driving the goals and objectives in accordance with corporate and site goals, and coordinating efforts to achieve compliance with ISO 9001, ISO 17034, ISO 13485 and applicable sections of ICH Q7 standards by performing the following duties personally or through Managers.
Performs the Quality Management Representative role which includes:
- Ensure all Risk Management activities are executed and maintained according to all regulatory standards.
- Represent Quality for new and existing product development, manufacturing transfers and quality plan initiatives.
- Support protocol, procedure and specification development.
- Develop and foster strong relationships with key stakeholders within the facility and within broader PerkinElmer.
- Work on assigned projects, including corporate projects, with limited supervision
- Prepare for and Host FDA, ISO and Customer audits
- Manage Quality Management Review
- Actively participate in Operations and other business review meetings
- In conjunction with the Regulatory Affairs department, work to facilitate domestic and international regulatory requirements and registrations.
- Manage the corrective and preventative action process,
- Collect, analyze and report data from Nonconformities, Deviations, CAPA
- Manage the complaint handling process to ensure timely analysis, investigation and closure of complaints as well as reporting MDRs and Adverse Events, as necessary
- Ensure the effectiveness of QMS training program
- Manage Incoming Inspection and the Material Review Board Process
- Manage responsibilities in association with final product releases
- Manage the internal audit schedule and process; maintain all records of internal audits and respond to findings as necessary
- Ensures quality management system (QMS) are established, implemented and maintained
- Reports to top management on the performance of the quality management system
- Promotion awareness of regulatory and customer requirements throughout the organization.
- Managing internal and external audits
- Ensures that global quality initiatives are implemented and executed in a timely manner.
- Oversees the development and implementation of standards, methods and procedures for inspecting, testing and evaluating company products, and compliance to established standards and applicable regulatory requirements.
- Monitors audits of production and Quality Control areas.
- Supervises technical documentation writers, including coordinating needs across product families.
- Monitor customer satisfaction levels, monitor the trending of customer feedback/complaints and implement appropriate continual improvement projects
- Lead investigations and resolve potential product quality issues to improve efficiency.
- Drive corrective action necessary to ensure conformity with quality and regulatory specifications.
- Oversees generation and review of documents used in support of meeting all government and company standards and regulations.
- Works closely with the leaders of the various Engineering and Operations functions in Boston and other PerkinElmer sites to ensure that all systems and activities meet all required standards and are technically sound considering the corporate strategy.
- Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
- · Ensures that new products are introduced in compliance with global and local policies.
- Bachelor’s Degree
- 10+ years Quality Assurance experience in a regulated environment
- 5+ years management experience
- Experience working in a manufacturing and/or production environment
- Experience implementing and executing within ISO 13485, US FDA 820, and CMDCAS complaint Quality Management Systems
- Expertise in risk management, root cause investigation, corrective/preventive action, and data analytics practices, tools and principles
- Experience developing long-term strategic goals
- Experience establishing operational objectives and work plans
- Experience establishing and assuring adherence to budgets, schedules, workplans, and performance requirements.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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