Staff Manufacturing Quality Engineer

Position Summary

• Staff Manufacturing Quality Engineer provides quality assurance support for all aspects of New Product Introductions (NPI), including Design Controls/Transfer, Incoming /In-process control, Risk Management, and sustaining engineering. Furthermore, this role focuses on establishing strategies for Quality Engineering, risk management, inspection & testing, and suppliers for new product introductions in order to sustain product competitiveness while maintaining compliance with domestic and international regulations and standards.
• The role collaborates and build relationships with cross-functional stakeholders such as Product Development/R&D, Translation Science, Laboratory Operations, Design Assurance/Quality, QMS, Supply Chain and Equipment teams to develop ideas, information, use cases, and industry best practices in the implementation of IVD manufacturing program in a diagnostic laboratory environment.

Job Responsibilities
Design Controls

• Provide Quality Engineering support for the execution of quality assurance activities during design transfer phases of new product development.
• Support the design/manufacture transfer process to ensure compliance with the current design controls and transfer requirements and procedures.
• Ensure the integrity of design controls elements during Design Transfer including Design Input/Output validity, and completeness of Design V&V.
• Support the development of material specification and incoming inspection process including test method development and test method validation.
• Support Supplier Quality team to select, develop and qualify suppliers.

Process Controls

• Support process development, process characterization and establishment of process window. Capture process knowledge to facilitate subsequent process validation activities.
• Process Validation: Develop process validation strategies. Lead Process Validation activities including Process Validation master plans, protocols, execution and reports.
• Process Monitoring: Support process monitoring to ensure ongoing product quality, effectiveness and compliance using established statistical methods.
• Process Improvement: Continuously monitor and analyze production processes, identifying potential failure modes, risks, and controls, and opportunities for improvement and implementing corrective and preventive actions.
• Develop quality assurance practices for NPI, and/or Manufacturing Transfers.

Production Controls

• Ensure the efficient and timely transfer of Process knowledge and Quality systems knowledge to Laboratory (Manufacturing) Operations.
• Support the creation of production documents such as DMR (Device Master Record) and quality records such as DHR (Device History Record or batch records) for new medical device/IVD products.
• Coordinate the training of Laboratory Ops personnel, Quality Engineers and related personnel on new IVD manufacturing procedures, quality systems, equipment etc.
• Oversight and approval of new products related NC's & CAPAs.

Risk Management

• Support the development and introduction of new products, processes, and technologies, with focus on risk management.
• Conduct thorough risk assessments, utilizing tools such as FMEA (Failure Modes and Effects Analysis), to proactively identify and address potential product or process risks. Lead pFMEA and other risk management activities.

Sustaining Engineering and Change Controls

• Lead sustaining engineering and change control activities throughout product life cycle.

Compliance

• Drive a customer centric quality culture and maintain compliance to applicable standards, regulations and internal QMS requirements.
• Implement quality systems for IVD manufacturing while achieving product performance and quality objectives.
• Ensure that customer and regulatory requirements are incorporated into the product/process.
• Support audit preparation strategy and execution. Participate and interface with internal & external audits with the QA team.
• Support various QMS process including but not limited to NCs, CAPAs, deviations, and complaints root-cause investigations.

Inter-Organization Collaboration

• Build productive and collaborative internal/external professional relationships across various teams and functions associated with design transfer activities.

Other

• Provide ongoing Quality Engineering support for reagent quality control testing and product release throughout the product life cycle.
• Other duties and responsibilities as assigned.

Required Qualifications

• B.S. in Engineering, engineering related discipline or equivalent experience.
• 5+ years in Quality Assurance or related functional area such as Design Transfer/Manufacturing Transfer preferably in the IVD or medical device manufacturing environment.
• Conditions of Employment: Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification.

Preferred Qualifications

• A minimum of 3 years of experience working within FDA regulated environment, preferably in the IVD or medical device manufacturing space.
• ASQ-CQE, CQA experience preferred.
• Strong working knowledge of ISO 13485 and ISO 14971, FDA Quality System Regulation 21 CFR Part 820 or CGMP.
• Knowledge of, or experience with, CAP/CLIA, clinical/diagnostic labs, NGS Oncology or companion diagnostic (CDx) technologies is a plus.
• Experience with NPI processes and the challenges associated with them.
• Development and implementation of design and process controls (i.e. PDCA, DMAIC experience).
• Six Sigma Black Belt Certification preferred.
• Experience with FDA and GHTF guidelines on Process Validation and Control.
• Familiarity with ISO and FDA requirements on Design Controls and CAPA Methodologies.
• Experience participating and providing support during third party audits such as BSI, FDA, others.
• Experience with Design for Manufacturing.
• Manufacturing Experience, or New Product Development/R&D experience.
• Knowledge of Poke Yoke (Error-Proofing) techniques.
• Application of statistical techniques.
• Human Error Prevention and/or Reduction techniques.
• Our ideal candidate will embrace working in a fast-paced, entrepreneurial, and collaborative environment; be a self-starter, independent, results-oriented team player with a demonstrated ability to manage multiple projects and deadlines including shifting priorities.

Physical Demands

• Employee may be required to lift routine office supplies and use standard office equipment.
• Ability to sit for extended periods of time.
• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• This position requires periodic travel and some evenings, weekends and/or Holidays.

This job description reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.