The Manufacturing Quality Engineer is responsible for ensuring quality process and standards are in place and followed in the manufacture of RefleXion products. This person will engage with the New Product Introduction team to ensure that processes and procedures developed for design transfer comply with and enable compliance and efficient operations. They will support equipment qualifications and process validation activities in manufacturing to meet quality standards and regulatory requirements. They will represent the Quality Assurance function in manufacturing and will ensure that appropriate process controls are in place to ensure product conformity.
- Facilitate the design transfer for manufacturing activities from a quality perspective.
- Participate in cross-functional reviews of process FMEAs.
- Align manufacturing process instruction (MPI) and travelers with product/subsystems/system requirements and ensure that appropriate in process inspection steps are included.
- Monitor product quality performance through manufacturing data such as yield, rework and NCR’s and by applying statistical process control (SPC) and CPK analysis of critical raw materials/parts and process parameters.
- Participate in the selection of inspection equipment required to support tests necessary to support part/assemblies/product testing for both in process and product release activities.
- Work with engineering team to develop methods and write detailed Quality Inspection Plans (QIP) for incoming inspection for parts/assemblies/materials.
- Coordinate with engineering team to appropriately set the calibration requirements and preventive maintenance schedule for equipment/tools/fixtures.
- Conduct and support in Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for equipment/tools/fixtures and Test Method Validation (TMV) for tests and inspection processes.
- Design and conduct gage R&R (Reliability and Repeatable) testing.
- Ensure continuous traceability from purchase order, to drawing, to PLM, to ERP system and that all traceability is documented, linked or captured in DHR.
- Conduct root cause analysis using appropriate methods (e.g. fishbone diagram, 5 whys, DMAIC) and implement corrective actions for identified issues.
- Coordinate and perform quality process audits for compliance with standards and regulations.
- Report on level of systems compliance, areas requiring changes or improvements and recommend corrective actions and track and document related efforts and results.
- Monitor findings for verification of effectiveness and ensure closure of related tasks.
- Perform other duties as assigned.
- Bachelor of Science (BS) Degree in Engineering or related technical discipline or equivalent experience
- American Society for Quality Control (ASQ) Certified Quality Engineer and/or lead auditor certification a plus
- Experience applying regulatory standards and process control measures to complex electromechanical capital equipment and related software.
- 6 Sigma Black Belt or CQE certifications preferred.
- Minimum three 8 years’ experience in manufacturing quality in a medical device design, manufacturing, or quality engineering capital equipment environment
- Experts understand of sampling methods such as Acceptance Quality Limit (AQL) and Lot Tolerance Percent Defective (LTPD).
- Strong understanding of ISO 14971:2012 Risk Management including Failure Mode and Effects Analysis (FMEA).
- Strong communication skills, both written and oral
- Experience in manufacturing medical devices in conformance with Food and Drug Administration (FDA) 820 Quality System Regulation and International Organization for Standards (ISO) 13485:2016 required
Company Benefits and Perks – What you will love about us!
All positions at RefleXion are eligible to receive the same benefits, listed here. We also want to highlight the following perks that add to our collaborative and team-work company culture. As we continue to grow as a company, we strive to have these benefits and perks grow with us – we are so excited for what is in store!
- The opportunity to work with a passionate, driven team in a pre-IPO start-up environment
- Competitive compensation and stock option package
- Three (3) weeks PTO to start
- Medical (both HMO and PPO options), Dental and Vision
- Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
- Employee Assistance Program (EAP)
- Employer paid Life Insurance.
- RefleXion Benefit Hub – for company exclusive discounts and deals on a variety of sites and items.
- Free daily on-site lunches
- Kitchens filled with a variety of healthy and delicious snacks and drinks – including espresso and soda machines!
- Company culture building events such as Coffee Chats with the Executives, Friday Afternoon Ice Cream Socials, and monthly Book Club
- On-site mobile car wash services weekly
- Electric car charging stations on site