Sr. Design Quality Engineer I

Job description

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 position is for a Design Quality Engineer Il with hands-on experience and proven success in managing Design Quality systems.

The successful candidate will be responsible for partnering with sterilization and microbiology Subject Matter Experts to assist in root cause investigations related to sterility and microbiological design outputs, review and assess the accuracy and sustainability of product requirements as they pertain to sterility assurance and microbiology and drive cross-functional collaboration with design quality groups across the organization.

This role requires a strong quality mindset, a willingness to learn about sterilization and microbiology, an understanding of medical device quality systems, and a commitment to ensuring product safety and compliance.

The ideal candidate should demonstrate proficient experience with quality management concepts including but not limited to eQMS, risk assessment, DFMEA, process controls, root cause investigations, CAPA, and continuous improvement

**SUPERVISION RECEIVED**

Under direct supervision of Sr. Quality Compliance Manager, Environmental Controls.

**SUPERVISION EXERCISED**

Indirect supervision of CMP QMS Workstream Team Members.

**ESSENTIAL DUTIES AND RESPONSIBILITIES**

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

**Process Oversight:**

+ Assist in root cause investigations related to integration of sterility and microbiological requirements during design and product risk management.
+ Review, assess, and update product and risk mitigation requirements as they pertain to sterility assurance and microbiological endpoints.
+ Collaborate in the development of a risk based approach to defining sterility-related and microbiological requirements.

+ Drive integration of product sterility considerations into product risk files.

+ Ensure compliance with industry standards such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements.

**Cross-Functional Collaboration:**

+ Work closely with sterility assurance and microbiology teams to ensure sterilization and microbiological processes are integrated into the overall product risk management process.

**Regulatory Compliance & Documentation:**

+ Ensure thorough documentation and records related to sterility assurance and microbiological endpoints as they pertain to design and risk management files.

+ Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.

**DESIRED MINIMUM QUALIFICATIONS**

+ Bachelor's degree in science, Engineering (Biomedical or Mechanical) or related discipline, with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or equivalent education and years of experience.

Or, master's degree in science, Engineering (Biomedical or Mechanical) or related discipline, with 0-2 years of experience, or equivalent education and years of experience.
+ Demonstrated knowledge and understanding of applicable national and international regulations and standards for Design Controls.
+ Demonstrates excellent organizational, verbal and written communication skills.
+ Proficient with the MS Office Suite, and statistical software.
+ Must be able to work independently with minimal supervision.
+ Able to prioritize projects and manage time to meet organizational goals and objectives.
+ Experience with External Regulatory Agency audits (i.e., Notified Bodies and FDA).
+ This position could require up to 25% travel.

**Preferred Skills:**

+ Experience using eQMS software solutions.

+ Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards.

+ Experience using analytical tools to drive data-based decision making.

**TOOLS AND EQUIPMENT USED**

*Knowledge of Visio and other process improvement tools required.

Salary Pay Range:

$81,650.00 - $112,700.00 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)

Required Skill Profession

Other General