Person, Text, Face

Senior QA Specialist, Post Market Surveillance

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Senior QA Specialist, Post Market Surveillance is responsible for implementing, documenting, and reporting post market surveillance data in compliance with FMI processes. This role leads timely complaint investigations, adverse event reporting, and recall management for FMI. The Senior QA Specialist works closely with cross functional teams within FMI to promote post market surveillance awareness and global complaint management requirements. This may include communicating with the FDA for recalls, MDRs, periodic updates, etc. Additionally, this role is responsible for supporting relationships with FMI partners in post market surveillance matters to meet quality agreement commitments.

Key Responsibilities

• Partner with FMI Client Services and Operation management to facilitate complaint investigations and closure across all FMI sites.

• Partner with cross functional team members to promote proper investigation and timely reporting.

• Assist the Director of Post Market Surveillance (PMS) as a Subject Matter Expert on post market surveillance matters when needed

• Participate in continuous improvement activities with the FMI sites to improve efficiencies in post market activities.

• Support FMI IT projects impacting the post market function and/or systems (eQMS).

• Support the facilitation and execution of a regularly scheduled complaint meeting with cross-functional groups evaluating customer feedback and escalate any potential issues in a timely manner and per process.

• Oversee complaint investigations, ensuring that all process requirements are met and documented in a timely manner.

• Ensure FMI employees follow PMS documentation required in FMI processes for compliance to global regulatory requirements

• Become the subject matter expert for complaint management during external audits/inspections by regulatory authorities (i.e. Notified Bodies, FDA, etc.).

• Maintain availability to work outside of regularly scheduled shift.

• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree with 5+ years of experience in medical device, diagnostics, or biopharmaceutical industry with direct involvement in Post Market Surveillance; OR,

• Master’s Degree with 3+ years of experience

Preferred Qualifications

• Degree in science or engineering discipline

• Working knowledge of ISO 13485, FDA CFR 820, FDA CFR 806, FDA CFR 803 and emerging standards and regulations related to post market and vigilance activities (IVDR)

• Knowledge of laboratory standards CLIA, CAP, ISO 15189, NY state and post market requirements

• Knowledge of IVD device complaint management and post market surveillance

• Continuous improvement experience (6 Sigma, Lean, GreenBelt/Black Belt)

• Demonstrated use of time management skills to drive individual/team projects to scheduled completion

• Ability to work in a matrixed organizational structure, developing strong relationships with all levels of management

• Ability to manage timelines and work independently to meet timelines as required

• Strong data analysis skills

• Strong interpersonal, verbal, and written communication skills

• Exceptional organizational, negotiation, and problem-solving skills

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

 

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

Apply Now

Internal applicants, please use your FMI email address.

Please let me know about more jobs like this

Not You?

Thank you

Recommended Jobs

Regulatory Affairs Specialist

Regulatory 100825 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States R&D
About the Job The Regulatory Affairs Specialist performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to the FDA for approval of novel platforms. The position prep...

Account Executive II - Los Angeles

Sales 100685 United States United States Commercial
About the Job The Account Executive II (AE II) is a field-based role with direct customer engagement on the Sales team within FMI’s Commercial operation. The position is responsible for selling FMI’s suite of specialty products and services, whil...

Associate Director, Financial Planning & Analysis

Corporate Management 100814 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Corporate
About the Job The Associate Director, Financial Planning & Analysis (FP&A) plays an integral role in the financial planning, reporting, and analysis process for Foundation Medicine. The position assists in the preparation of financial pla...

Vice President, Total Rewards

People Team 100868 Boston Massachusetts United States Seaport Blvd., Boston, Massachusetts, United States Corporate
About the Job The Vice President, Total Rewards leads the FMI total rewards strategy and tactics with an innovative approach and a continuous improvement mindset to build on and evolve current total rewards philosophy and programs. This role is f...

Send to a friend

Not You?

Thank you for sending this job to your friend.

Person, Clothing, Shoe, Crowd, Sitting, People, Wood, Pants, Face, Coat

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.