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 cooperative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in 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.

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.

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 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. 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).

Excellent written and verbal communication skills with good presentation and technical writing skills. Proficiency in all Microsoft Office programs. 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. national origin; disability;

📌 SENIOR QUALITY ENGINEER - MEDICAL DEVICE ENGINEER #5452 (British Columbia)
🏢 MassMEDIC
📍 British Columbia