Supplier Quality Engineer

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 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.

This position requires a strong team player with a quality engineering background working in integrated product teams and a desire for maintaining a high commitment to both new and sustaining production. Works under only general direction. Independently determines and develops approaches to solutions. Frequent interorganizational collaboration and external supplier contact. Represents the organization in providing solutions to difficult technical supplier issues associated with specific projects.

This is an on-site role.

• Represent quality initiatives and compliance projects for our client.
• 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.
• 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.
• Update documentation as required per the remediation plan
• Provide support for CAPA/NCRs/Complaint evaluations.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Bachelor’s Degree in Engineering.
• Minimum of five (5) years direct Quality/Design Quality engineering experience in medical device industry required.
• Demonstrated used of quality tools/methodologies including SPC, DOE, GR&R, FMEA, CAPA, MSA, and process validation (IQ, OQ/PQ).
• Must have a good understanding of FDA 21
  
  CFR
  820, ISO 13485, and ISO 14971.
• Demonstrated interpersonal skills with the ability to work within a team environment.
• Excellent written and verbal communication skills with good presentation and technical writing skills. Proficiency in all Microsoft Office programs.
• Good analytical and problem-solving skills. Strong engineering, design, and analysis skills.
• Working knowledge of tooling and manufacturing processes.
• Experience with medical devices from concept to commercialization.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.