Quality Engineer II - HHE (Health Hazard Evaluation)

Integra LifeSciences•Princeton, FL

16d

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. This Quality Engineer II is responsible for leading and executing Health Hazard Evaluations (HHEs) and supporting product Field Actions. The Quality Engineer II will work cross functionally with all manufacturing sites, design assurance, medical affairs and other SMEs involved in the HHE process. He/She will have e xposure and visibility to leadership on issues related to product quality, safety and/or performance is inherent with this role. A solid understanding of US and international regulations is required (21 CFR, MDSAP, EU MDR, etc.) We need applicants that have experience in the Medical Device industry with Health Hazard Evaluation (HHE) risk assesment.

Requirements

Bachelor’s degree in a scientific discipline required, preferably Biomedical Engineering; strong analytical skills, exceptional writing and interpersonal relationship skills.
3-5+ years’ experience working in a medical device organization, specifically in a Quality role.
Computer skills to include knowledge and proficiency with Excel, SharePoint and proficient use of the worldwide web network.
Strong writing, project management, problem solving, and communication skills.
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

Nice To Haves

Experience working in Oracle, Agile and TrackWise systems preferred.

Responsibilities

Lead and coordinate all required activities, such as cross functional meetings, to support the completion of HHEs.
Ensure HHE documentation is complete, accurate and addresses regulatory requirements prior to approval.
Prepare HHE documentation to be presented to Product Safety Board that includes the Corporate VP of Quality, Corporate VP of Regulatory and Corporate VP of Legal.
Present HHE information at Product Safety Board alongside the other SMEs.
Continually monitor and provide routine metrics to management on the progress of HHE's and Field Actions.
When an HHE results in a Field Action, support the initiation of that Field Action and any required logistics needed.
Ensure Field Action documents are maintained and archived appropriately.
As needed, prepare documents required to be submitted to the FDA for periodic updates and/or termination requests.
Provide support and/or participate in regulatory audits/inspections as required.
Write and/or revise department procedures as needed.
Keep apprised of new regulations, standards, policies, and guidance documents issued by relevant regulatory authorities that may impact HHE's and/or Field Actions.
Perform all other related duties as directed by management.
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 HHEs.
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.