SENIOR SUPPLIER QUALITY ENGINEER OR MANAGER*
*Title will be commensurate with experience and skillset of candidate
Position Title: Senior Supplier Quality Engineer or Manager*
Position Type: Full Time
Job Type: Experienced
Reporting To/Department: Senior Vice President of Quality
Lumicell is seeking a highly motivated Supplier Quality Engineer to work in a dynamic, fast-paced start-up environment on a combination drug-device product. Lumicell is developing a breakthrough surgical guidance technology platform consisting of a proprietary drug that is activated by the micro-environment of cancerous tumors, a custom fluoroscope that allows a surgeon to visualize activated drug, and a software system that gives a real-time prediction of tissue likely to be cancerous. This is an exciting opportunity to join a company that has received excellent press and generated promising clinical data while still in its early development.
The successful candidate must have a thorough understanding of Supplier Controls and Process Validation in the medical industry. The successful candidate is methodical and a process-oriented who integrates well into existing company processes while adapting to new roles as necessary and can gradually take on increased responsibility and project ownership.
The Supplier Quality Engineer will be an integral part of the quality team to ensure our suppliers operate in compliance with regulatory and Lumicell requirements. In addition, this person will work cross-functionally with the engineering team for both onboarding new suppliers, especially contract manufacturers, and monitoring the performance of existing suppliers in a sustaining role.
Essential Duties and Responsibilities:
- Lead supplier selection, supplier onboarding and process validation activities at Lumicell’s contract manufacturing sites (including oversight of Master Validation Plans, IQ / OQ / PQ’s, pFMEAs, etc)
- Manage the Lumicell Approved Supplier List for both device and drug suppliers, as well as associated Supplier Controls SOPs and Work Instructions
- Act as a member of Lumicell cross-functional project teams, including Design Controls teams, to provide supplier quality input and drive supplier decisions
- Collaborate with the sustaining engineering team to investigate NCMRs, CAPAs, deviations, complaints, etc. related to product for human use (including both clinical trial and commercially available product)
- Participate in supplier audits on behalf Lumicell (standards in scope include ISO 13485, ISO 11135, ISO 17025, PIC/S, ICH Q7A)
- Show exceptional attention to detail and ability to effectively and accurately document test results
- Confidently communicate and present findings to the team, other engineering disciplines, and senior management
- BS in Biomedical, Mechanical, or Electrical Engineering or other technical discipline
- Minimum 3 years of experience in the medical device field with a process validation focus in a regulated environment (510k, PMA)
- Experience leading supplier audits and/or auditing credentials (ex: ASQ Certification) preferred
- Experience with medical imaging, fluorescence imaging and/or optoelectronics preferred
- Experience with pharmaceutical manufacturing supplier qualification and process validation preferred
- Familiarity with 21 CFR 820, ISO 13485, ISO 11135, ISO 17025, ISO 14971, ISO 11137, 21 CFR 210, preferred
- Excellent problem-solving, troubleshooting, written and spoken communication skills
- Detail-oriented and highly organized
- Must be able to work independently and as part of a team, learn quickly, and take on responsibilities outside of this scope of work, as necessary
- Must have strong patient and user focus with patient outcomes in mind
- Must be resilient and focused with a knack for navigating complex and occasionally ambiguous environment
- This position does not currently have supervisory responsibilities.
- This job operates in a professional office/ laboratory environment, in addition to a manufacturing environment for supplier visits. This role routinely uses standard office equipment such as laptop computers, photocopiers and smartphones, as well as exposure to various test and manufacturing equipment, etc.
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.
- Travel will be required as part this position. Lumicell anticipates travel will be required for approximately 50% of the time during the first year to local manufacturing sites (MA and NH). Travel requirements will likely decrease to 10-20% after the first year.
- Lumicell is an equal opportunity employer
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
To apply for this position, please send your resume to firstname.lastname@example.org.