Quality Engineer II, Post Market Surveillance

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The Quality Engineer II, Post Market Surveillance is directly responsible for the development of Periodic Safety Update Reports (PSURs) for Integra’s Class II and Class III Medical Devices and Post Market Surveillance Reports (PMSRs) for Integra’s Class I, and non CE marked Medical Devices.  This role is critical in ensuring compliance to Medical Device Regulations worldwide and to ensuring the safety, quality and performance of Integra devices remains a top priority for our patients and the customers that we serve throughout the lifetime of the device. This position will work cross functionally with many different departments within the business. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Responsible for collaborating and gathering all required active and passive post market surveillance data for analysis and utilization to support appropriate outputs ensuring product safety, quality, and performance. 

• Utilize critical thinking to ensure a holistic approach is applied to assessing all post market surveillance data inputs and recommendations for outputs is thorough and concise 

• Act as a Post Market Surveillance Subject Matter Expert for all Notified Body and Regulatory Body communications 

• Facilitate and lead all communications with appropriate stakeholders as it relates to Post Market Surveillance activities 

• Collaborate closely with many different functions including Site Quality, Clinical Operations, Medical Affairs, Design Assurance, Regulatory, Product Development and the Commercial Team 

• Participate in Quality Management Review Boards and Product Safety Board meetings as applicable 

• Facilitate and ensure all outputs of Post Market Surveillance activities is captured and followed through with the appropriate SME(s)

• Communicate any significant safety, quality and/or performance issues to leadership as appropriate 

• Ensure accuracy and timeliness of all PSURs submissions to the Notified Body, Eudamed and/or Competent Authority as applicable 

• Responsible for any changes or updates to the applicable Global Operating Procedures and/or Templates 

• Participate in internal or external audits as the Subject Matter Expert for Post Market Surveillance 

• Participate in site or global projects and improvement efforts, as needed

• Keeps apprised of new regulations, standards and/or processes that impact complaint handing and regulatory reporting responsibilities 

• Other duties as assigned

Minimum Qualifications

• Education: Bachelor’s degree in a scientific discipline required, preferably Biomedical Engineering or Nursing

• Experience: Minimum 3 years of experience working in a Post Market Surveillance function within a fast-paced medical device company    

• Strong analytical skills, exceptional writing and interpersonal relationship skills 

• Demonstrated knowledge of FDA regulations 21 CFR 803, 820, ISO 9001, ISO 13485:2016, Medical Device Directive Regulation (93/42EEC), Medical Device Regulation (2017/745), MDSAP and other national and international regulations and standards.

• Experience with direct contact with the FDA and ISO Notified Bodies. 

• Knowledge of complaint handling, regulatory reporting, NC/CAPA, process design and implementation, change control, auditing, and document management systems.

• Experience working in Oracle, Agile and TrackWise systems preferred.

• General knowledge of statistical analysis.

• Demonstrated organizational, management and communication skills.

• Must be able to observe company policies and safety procedures at all times.

• Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.

• Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.

• Must be able to work independently with minimal supervision.

• Must be able to prioritize projects and manage time effectively

TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, and copy machine as well as other general office equipment. Strong computer skills (Microsoft Office (W