Senior Quality Engineer - Medical Device #9557
About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About the role
The Senior Quality Engineer primary role is to enhance production processes to ensure efficiency, quality, and safety. This role requires collaboration with cross-functional teams, strong problem-solving abilities, and a deep understanding of manufacturing systems to drive success.
Responsibilities
- Review and approve change requests related to Product, Process, and Validation and Verification documentation.
- Develop quality documentation such as quality plans, standard operating procedures, and inspection procedures.
- Ensure regulatory, FDA, and ISO compliance in all areas of responsibilities.
- Represent Quality initiatives and compliance when participating and Design and Phase reviews
- Identify industry best practices.
- Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Ensure that required standards for products are documented in the product requirements (PR) specification and ensure compliance by performing quarterly gap analysis and reviewing applicable verification documentation.
- Ensure the use of statistically valid sampling techniques and teach others on the use of these and other advanced statistical techniques such as DOE and ANOVA
- Review and approve Process Qualifications, Test Method Validations, Gage R&R's, Process Capability studies, Design of Experiment (DOE), FMEAs (Design and Process), and production master control plans.
- Provide support for CAPA/NCRs/Complaint evaluations.
- Provide direction and lead the implementation of Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans, product/component testing, inspections