Sr. Design Quality Engineer I
Sr. Design Quality Engineer I
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1 Vacancy
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 whats 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 toassist 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
- Bachelors 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 masters 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.
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.
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Required Experience:
Senior IC
Employment Type
Full-Time
