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Quality Engineer II - HHE (Health Hazard Evaluation)

Integra LifeSciences

Princeton, NJ

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JOB DETAILS
SALARY
$71,300–$97,750 Per Year
SKILLS
Agile Programming Methodologies, Analysis Skills, Biomedical Engineering, Code of Federal Regulations, Communication Skills, Computer Skills, Corporate Policies, Cross-Functional, Documentation, Establish Priorities, External Audit, Healthcare, Internal Audit, Interpersonal Skills, Leadership, Legal, Logistics, Manufacturing, Medical Affairs, Medical Equipment, Medical Organizations, Metrics, Microsoft SharePoint, On Site Support, Operations Processes, Oracle, Problem Solving Skills, Product Safety, Project/Program Management, Quality Engineering, Regulations, Regulatory Reports, Resume Search, Safety Process, Standards of Care, Team Building, Team Lead/Manager, Time Management, Writing Skills
LOCATION
Princeton, NJ
POSTED
30+ days ago
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 exposure 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.


ESSENTIAL DUTIES AND 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.


DESIRED MINIMUM QUALIFICATIONS:

* Education: Bachelor's degree in a scientific discipline required, preferably Biomedical Engineering; strong analytical skills, exceptional writing and interpersonal relationship skills.

* Experience: 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.

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

* 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


Salary Pay Range:


$71,300.00 - $97,750.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.


Additional Description for Pay Transparency:


Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).


Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/


Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.


This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)


Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.


Unsolicited Agency Submission


Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.


Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)

About the Company

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Integra LifeSciences