Supplier Quality Engineer

Job Description

Job Description

Salary:

At Lumicell, well give you the opportunity to harness all thats within you by working in a mission driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery. We are working to revolutionize the way cancer surgery is performed today, starting with breast cancer. Women in the US have a 1 in 8 lifetime risk of being diagnosed with breast cancer. Every two minutes, a person is diagnosed. Our founder, David Lee lost his wife to breast cancer due to cancer being left behind during surgery. You will be a part of something groundbreaking as we transition from clinical development to our commercial launch.

The Supplier Quality Engineer position is a hybrid role based at our Newton, MA site, that reports directly to the Head of Quality, and will be responsible for the quality management of the Contract Manufacturing Organization (CMO) and other critical suppliers supporting the development and manufacturing of Lumicells flagship product. This position is responsible for the management & control of these suppliers in compliance with applicable standards of GMP and Lumicell procedures.

Additionally, this position will support internal quality operations, as needed.

This role will partner closely with the Product Development, Operations and Quality teams. Strong collaboration and communication skills will be required to effectively work in a startup environment.

Responsibilities:

• Provide quality guidance and leadership to contract manufacturing sites and critical suppliers.
• Manage supplier qualification and process validation activities at Lumicells CMOs and critical suppliers.
• Support design transfer activities and assist in the creation, review and approval of manufacturing deliverables.
• Lead supplier audits on behalf of Lumicell (standards in scope include 21CFR820 and ISO13485).
• Provides quality oversight for assessments of Supplier Change Notifications from suppliers, including change impact assessments, and owning/driving change actions through implementation.
• Collaborate with suppliers to drive resolutions to non-conformances identified with suppliers.
• Monitor performance of suppliers and initiate corrective action as required.
• Reviews and approves investigations/corrections performed by a supplier.
• May assist in preparing for and hosting of regulatory inspections/audits.

Competencies for Success:

• Experience in the medical device, biotechnology and/or pharmaceutical industry.
• Experience with electro-mechanical and opto-mechanical products is required.
• Experience with EtO sterilized single use disposables is required.
• Experience with managing multiple CMO partners.
• Self-motivated, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment.
• Strong verbal and written skills.
• Hands-on experience with process validation (IQ. OQ, PQ) preferred.
• Flexible and able to respond quickly to shifting priorities.
• Thorough understanding of quality systems, cGMPs/cGDPs
• Fluent with electronic Quality Management Systems (eQMS); Arena preferred
• Experience leading, training and/or implementing root cause analysis and effective investigation practices.
• Knowledge of statistical techniques.
• Certified Quality Auditor

Qualifications

• A minimum of 3 years with at least one year of experience managing CMOs in a regulated environment.
• B.S./B.A. Degree (related field preferred), or equivalent relevant experience.

Position Type/Expected Hours of Work:

• This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.
• This is a Hybrid position, and the ability to be on-site as needed is required.

Travel:

• Travel should be expected for this position for approximately 40% of the time.

Lumicell is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.

Lumicell is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Lumicell will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.