The Sr. Quality Engineer is responsible for the application of quality engineering principles to supplier engineering, manufacturing processes, sustaining engineering, and new product introduction. Responsibilities include supporting line down situations, NCRs, deviations, test method validation, process validation, equipment qualifications and statistical techniques. A working knowledge of risk management and production processes necessary to build highly complex capital equipment is key in this role. The Sr. Quality Engineer represents the Quality Assurance function with suppliers, manufacturing and R&D and will ensure that appropriate process controls are in place to ensure product conformity. A strong statistical & GD&T background is a plus. The ability to make data driven decisions is critical to this role.
- Address quality issues situations utilizing technical insight to seek root causes and documenting findings and solutions utilizing appropriate QMS tools such as NCRs, Temporary Deviations (TDs), SCARs, SCRs, Supplier Controls, and Change Orders.
- Analyze issues to collaborate on root causes and work to prevent reoccurrence. This responsibility includes interfacing with suppliers to resolve issues.
- Acts as both an onsite Quality Engineer for onsite manufacturing and a supplier Quality Engineer for their business unit.
- Assess potential new suppliers for technical, quality, QMS maturity, and manufacturing capabilities.
- Participates or leads supplier audits to evaluate technical abilities, quality capabilities, and QMS maturity.
- Provides technical support for the introduction of components from a new supplier.
- Analyzes incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers.
- Reviews new design specifications and provides input from component quality and manufacturability perspective.
- Drive risk-based evaluation of data and implementation of processes using a risked based approach and sound statistical techniques.
- Create and continuously update quality processes that are efficient, compliant, and scalable to support a growing organization.
- Support initiatives of higher-level objectives such as QMS updates to meet international standards and regulations (e.g. EU MDR).
- Work with Manufacturing Engineering to drive continuous improvement through business and quality objectives and resolve issues that could impact product quality or regulatory compliance.
- Provide Quality Engineering support for production; addresses non-conformances through the NCR/CAPA system - driving escalation when risk level warrants it - and participates in complaint investigations (if needed).
- Work with Manufacturing and Technical Service organizations to resolve non-conformances and identify opportunities for improvement.
- Key participant in monthly QMS reviews and management review meetings; compile and analyze quality metrics and data with the objective of establishing goals and identifying trends. (NCR/TD/Rework)
- Provide support for internal audits, third party audits, FDA inspections, and Notified Body audits.
- Lead cost reduction projects, using Six Sigma and Lean Business methodologies as well as supporting projects driven by other functions where quality oversight is needed.
- Interface with all internal departments to proactively identify potential issues and develop solutions to minimize or prevent adverse effects on products.
- Assure finished products conform to regulations and applicable standards satisfying the QSR, ISO, and other relevant requirements.
- Perform other duties as assigned.
- Soft skills – a team player, ability to pivot quickly to address issues critical to business success, ability to articulate a complex issue to a actionable item(s) and prioritize work effectively.
- BS in Engineering or life sciences (Mechanical or Electrical Engineering preferred).
- 6-10 years of Quality-related experience in the Medical Device industry
- Solid organizational, analytical and problem-solving skills.
- Strong computer skills, particularly with MES, PLM, Minitab or JMP, ERP/MRP, MS Office and Adobe Acrobat.
- Excellent interpersonal, communication and presentation skills, both verbal and written
- Solid understanding of QSR, MDR, ISO 13485, and 14971. Familiarity with IEC 62304, 62366 and 60601 standards preferred.
- Experience performing PFMEA, IQ, OQ, PQ, DQ, and TMV.
- Reviewing assemblies/drawings in SolidWorks a plus.
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
- 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