Senior Quality Engineer - Medical Engineer

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. The roles will support Quality System integration deliverables including but not limited to maintaining site compliance matrix, updating acquired entity’s QS as the QS is integrated, maintain and update quality plans associated with integration activities.

In addition, support and execute Design Assurance deliverables for product integration activities including DV, DVAL and Usability.

• 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, and acceptance criteria.
• Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assists in special projects as needed.
• Contributes to team effort by accomplishing related duties as requested.

• Bachelor’s degree in engineering.
• Minimum of five (8) 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, and process validation (IQ, OQ/PQ).
• Must have a good understanding of FDA 21
  
  CFR
  820, ISO 13485, 14971, and 11607 standards.
• 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.
• Understanding of FDA Quality Systems Regulations.

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.