Surveillance Operator jobs in Methuen, MA

We're Hiring! At Dräger, it is our passion and dedication to protect, support and save lives. Our dedication to life naturally extends to the quality of our employees’ lives.

They are the essence of our company, and without them, we would not be what we are today a world leader in medical and safety technology.

We are searching for people who want to join us in building Technology for Life .

This role is based out of our beautiful Andover, MA facility which offers many benefits including an on-site fitness center with yoga and fitness training classes, on-site game rooms, full-service café, free parking and more.

Andover supports the design and assembly of our patient monitoring products.

In this role :

As an Independent Quality and Regulatory Professional, this will require minimal direction / oversight and responsibility for all facets of Post Market Surveillance activities.

This position will be responsible to ensure successful compliance execution of post-market processes and eagerly contribute to the continued development and improvement to the Complaint Handling Process.

Represents Post Market Surveillance function during FDA Inspections (QSIT and / or For Cause), ISO Notified Body audits, Competent Authority and customer audits, and internal audits.

Corresponds with Regulatory Agencies to ensure compliance. Acts as a mentor to junior staff / engineers. Ensures applicable, local, country, and international regulatory requirements are met.

Supports field safety corrective actions / recalls, as required.

Provides oversight to the team with respect to vigilance reporting with FDA, EU MDR, CMDR, MDSAP and others. Foster and amplify post-market surveillance and compliance awareness within DMSI.

Review and summarize the results of Quality CAPA and HHE investigations. Works closely with Sales and Service to solve customer issues.

Support health hazard analyses / risk assessments as applicable.

• Oversee the complaint and reportable event lifecycle as well as the maintenance and surveillance mechanisms and periodic reporting to identify potential risks and opportunities for improvement.
• Lead, ensure, and support processes and actions related to detection of, and response to, product safety and performance signals
• Provide support to Quality and other internal and external stakeholders regarding CAPAs and SCARs that have escalated from complaints or reportable events.
• Assist with preparation, notification, tracking and reporting of recalls and other field actions, as necessary, including clinical stock recoveries.
• Develop, maintain, and ensure methods, tools, and procedures to conduct and support post-market risk management activities to help enable an integrated holistic total lifecycle risk management strategy applied to commercial products
• Ensure that the Draeger processes and supporting information are compliant with applicable global regulations and standards as well as applicable regional and or country specific requirements.
• Determine trends that result in corrective action, report complaint trends to management and assist in Post Market Compliance activities, including Field Safety Corrective Actions / recalls related to complaints.
• Facilitate, and ensure cross-functional review to enable effective vigilance and generation / revision of post-market plans and reports
• Represents Complaint Investigation during FDA Inspections (QSIT and / or For Cause), ISO Notified Body audits, Competent Authority and customer audits, and internal audits
• Provides mentorship to junior engineering staff and leadership within department. Clearly communicates work and concepts to team members, leads, and managers.

Identifies and proposes strategies around technical problems affecting their work and team

Performs other duties as needed and assigned.

Education :

Bachelor’s degree in a technical discipline or the equivalent in education, training and related experience.

Related Experience :

• 10 years of experience in a related discipline
• Root-cause determination through applied statistical methodology or other quality tools
• Experience preparing communications with FDA and foreign Competent Authority groups. Previous clinical exposure a plus
• Medical Device experience preferred

Special Competencies or Certifications :

Ability to engage and manage multi-level and multi-discipline project work teams to coordinate activities related to complaint investigation and closure.

Strong influencing and negotiation skills at all levels. Effective communication (written, verbal, presentation), teamwork and leadership skills.

Ability to perform job duties by demonstrating initiative and operating autonomously.

• Expertise in FDA Quality System Regulations (21 CFR Part , , ), ISO , ISO , MDR
• Strong communication, teamwork and leadership skills
• A self-starter that is part of the solution and results oriented
• Six Sigma certification to DMAIC methodology preferred

Work Environment / Conditions :

• Ability to work together with others and in a team atmosphere; while displaying civility, cordiality, friendliness, empathy, etc.
• Ability to work in a fast-paced environment with varying amounts of individual responsibilities, conflict resolution, redirected priorities, etc.
• Occasional travel nationally / internationally

Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia.

We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.

The design, development and manufacturing of Draeger’s Patient Monitoring product line takes place in our Andover, Massachusetts location.

EEO is the Law

Draeger is an Equal Opportunity Employer. To learn more :

From hospitals to fire departments to industrial customers, people around the world rely on our products : cutting-edge technology that combines real engineering with the digital future.

With over years of experience, passion and the bold ideas of more than 16, employees, we are committed to turning technology into technology for life .

Benefits

Dräger is responsible for life. The lives of our employees are especially important to us, therefore, Dräger believes in fostering a culture that places the focus on employee health & wellbeing, both in the office and at home.

We offer a generous benefits package that includes, comprehensive medical, dental & vision coverage, paid time off starting at 4 weeks per year, tuition reimbursement, k match, wellness and employee support programs, life insurance and more!

What we offer

• Health Insurance
• Retirement savings
• Health center and gym

Health Insurance; Retirement savings; Health center and gym

Last updated : 2024-04-23