New Product Introduction Quality Engineer
SUMMARY OF POSITION:
The purpose of the role of the NPI Quality Engineer is to participate in new product and process teams as well as assume responsibility for the development and implementation of quality engineered systems for new processes, products and transfer products. The NPI Quality Engineer is also responsible for evaluation and determination of quality requirements for new product introduction prior to release while assisting in the development, review and approval of process and equipment validation and qualifications (IQ,OQ,PQ,PV) while assuring appropriate testing and statistical methods are utilized. The NPI Quality Engineer provides technical guidance and support for the NPI Team including development activities and serves as in-house expert on Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), Gage R&R, SPC, Root Cause Analysis, Mistake Proofing, Poke Yoke, and Statistical Sampling. The NPI Quality Engineer supports customer and regulatory body audits and responses, provides assessments and offers advice on robustness of Quality System implementation.
MAIN JOB RESPONSIBILITIES:
- Works in Quality Engineering role with other functional groups, provides support of new process/ product and transfer products
- Works as the primary quality contact for the Customer during the NPI process
- Provides NPI Team direction, analysis and recommendations to assure effective quality control and associated risk management plans
- Writes Master Validation Plan to define overall NPI validation activities
- Writes, reviews and/or approves process and product validation protocols and reports, equipment qualifications, engineering change orders
- Provides technical leadership for Failure Mode and Effects Analysis (FMEA) and Control Plans for Process FMEA’s
- Owns the FMEA process
- Supports complaint investigations as appropriate
- Develops, writes and helps execute Test Method Validations
- Assures proper use of statistical tools to analyze data, make acceptance decisions, and improve process capability (DOE, SPC), throughout the organization
- Ensures that development activities follow control requirements and product is properly transferred to manufacturing
- Assures all control plans meet necessary requirements to ensure effective product acceptance including appropriate inspection requirements, equipment and gage requirements and sampling plans
- Initiates and investigates Corrective and Preventative Actions (CAPA) as appropriate
- Assures Operation Value Stream quality activities remain in compliance with FDA / ISO regulations/standards/guidelines and facility SOP’s and Customer requirements
- Leads continuous improvement activities and supports Lean environment and re-work/scrap reduction
- Supports annual Quality Improvement goals with Operations and Quality Leadership
POSITION REQUIREMENTS:
Education:
- BS in Engineering or related field
Experience:
- 5–10 years Quality Engineer experience
- Experience in medical device or other regulated industry
- Experience in product development
- Thorough knowledge of FDA QSR, ISO 13485, ISO 14971 Risk Assessment
- Skills/Competencies:
- Thorough knowledge of leading edge Quality engineering, design control, verification and validation tools and methodologies
- Demonstrated auditing and problem solving skills
- Demonstrated verbal and written communication skills
- Ability to train and mentor employees at all levels of the organization
- Understanding of business and financial metrics
- Working knowledge of statistical techniques and tools
- Working knowledge in spreadsheets, databases and word processing software programs
- Knowledge of computer software validation highly desirable
Physical Requirements:
- Some travel is required
- Work in an office environment with varying amounts of walking, sitting, standing, twisting and turning
- Periodically lift of carry up to 25lbs.
- No unusual or excessive physical demands
