Post Market Associate
NOVA Biomedical GmbH, Waltham, MA, United States
Nova Biomedical is an Equal Opportunity Employer in compliance with affirmative action in hiring and promoting women, minorities, veterans and individuals with disabilities.
Job Summary The Post Market Associate provides support to the QA function by performing activities associated with customer product complaints, including receipt, evaluation, investigation, trending, reporting, and closure. They also provide support for other functions such as Post‑market Surveillance (PMS).
What you’ll do
Primary ownership for complaints and post‑market surveillance utilizing the SalesForce platform.
Initiate complaint files and document complaint and regulatory reportability assessment within the Complaint Handling System per Advanced Instruments procedures, GMP’s, 21 CFR 803, 820, ISO 13485, and other applicable national regulatory requirements.
Make reportability decisions and submit MDR reports.
Conduct preliminary complaint investigations including DHR review, shipment and lot history review, and trending to aid in determination of root cause.
Update complaint records to reflect investigation findings, perform risk assessments, make corrective action assessments based on investigation findings, and close complaints.
Provide support to cross‑functional teams related to complaint management.
Work cross‑functionally to support CAPA investigations, root cause determinations and risk evaluations as required.
Trend complaint root causes to identify potential improvement opportunities.
In coordination with Regulatory Affairs (RA) document and implement PMS Plans for all product families.
Execute PMS plans in the commercial lifecycle by collecting information and data and completing PMS reports as required.
Provide assistance in controlled document management and quality records management.
Participate in internal and external audits.
Promote a culture of quality focused on compliance with customer needs and regulatory requirements.
Other duties as assigned.
What we are looking for in you
Knowledge of ISO 13485, MDSAP and FDA QSR required; other regulatory jurisdictions strongly preferred.
Must be able to use Microsoft Office, Adobe, and be comfortable in eQMS and ERP Company Software.
Experience with Salesforce and/or Epicor.
Experience with in‑vitro diagnostics (IVD / IVDR) is preferred; other applicable experience is a plus.
Familiarity with Power BI.
Physical Requirements for this role include
Minimum 4 days onsite requirement to support the business.
Must be able to use basic office equipment: Computer, Printer, Copier, Telephone, etc.
Must be capable of communicating with stakeholders.
Benefits
Competitive 401(k) company match.
Bonus Program, generous PTO and paid holidays.
Hybrid and flexible work arrangements (job specific).
Professional development, engagement and events.
Company marketplace for lunch and snacks! (location specific).
Company subsidized cafeteria (Waltham).
Work Location Hybrid in Norwood, MA
Schedule / Hours Monday to Friday, 8 AM – 4:30 PM
Targeted Salary Range $55,000 – $63,000 per year
EEO Statement Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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Job Summary The Post Market Associate provides support to the QA function by performing activities associated with customer product complaints, including receipt, evaluation, investigation, trending, reporting, and closure. They also provide support for other functions such as Post‑market Surveillance (PMS).
What you’ll do
Primary ownership for complaints and post‑market surveillance utilizing the SalesForce platform.
Initiate complaint files and document complaint and regulatory reportability assessment within the Complaint Handling System per Advanced Instruments procedures, GMP’s, 21 CFR 803, 820, ISO 13485, and other applicable national regulatory requirements.
Make reportability decisions and submit MDR reports.
Conduct preliminary complaint investigations including DHR review, shipment and lot history review, and trending to aid in determination of root cause.
Update complaint records to reflect investigation findings, perform risk assessments, make corrective action assessments based on investigation findings, and close complaints.
Provide support to cross‑functional teams related to complaint management.
Work cross‑functionally to support CAPA investigations, root cause determinations and risk evaluations as required.
Trend complaint root causes to identify potential improvement opportunities.
In coordination with Regulatory Affairs (RA) document and implement PMS Plans for all product families.
Execute PMS plans in the commercial lifecycle by collecting information and data and completing PMS reports as required.
Provide assistance in controlled document management and quality records management.
Participate in internal and external audits.
Promote a culture of quality focused on compliance with customer needs and regulatory requirements.
Other duties as assigned.
What we are looking for in you
Knowledge of ISO 13485, MDSAP and FDA QSR required; other regulatory jurisdictions strongly preferred.
Must be able to use Microsoft Office, Adobe, and be comfortable in eQMS and ERP Company Software.
Experience with Salesforce and/or Epicor.
Experience with in‑vitro diagnostics (IVD / IVDR) is preferred; other applicable experience is a plus.
Familiarity with Power BI.
Physical Requirements for this role include
Minimum 4 days onsite requirement to support the business.
Must be able to use basic office equipment: Computer, Printer, Copier, Telephone, etc.
Must be capable of communicating with stakeholders.
Benefits
Competitive 401(k) company match.
Bonus Program, generous PTO and paid holidays.
Hybrid and flexible work arrangements (job specific).
Professional development, engagement and events.
Company marketplace for lunch and snacks! (location specific).
Company subsidized cafeteria (Waltham).
Work Location Hybrid in Norwood, MA
Schedule / Hours Monday to Friday, 8 AM – 4:30 PM
Targeted Salary Range $55,000 – $63,000 per year
EEO Statement Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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