Quality Control Engineer (Medical Device)
The primary responsibility of the Quality Control Engineer (QCE) is to develop, implement, and direct processes and practices that result in the desired level of quality for manufactured parts and new products under development. The QCE ensures components/products/assemblies conform to specifications and all applicable product quality, design, Quality Management System (QMS) processes and procedure requirements. Provides leadership in quality assurance, new product development support, and continuous improvement activities. Maintains and develops procedures to ensure that statistical control is maintained in all manufacturing processes.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Drives a systematic approach in problem solving and process improvement using quality engineering tools such as Six Sigma, DMAIC, Statistical Process Control, Design of Experiment
- Explore and identify standards to measure the quality of a part or product, analyze factors that affect quality, and determine the best practices to ensure quality
- Act as a critical driver for preventative actions related to department processes and procedures to improve the quality and effectiveness of the company
- Conducts complaint investigations and work with internal and external parties in providing corrective and preventive actions based on sound data analysis and engineering approach
- Monitors, maintains, and reports on First-Pass Yield (FPY), Defect Per Unit (DPU), First Article Inspection (FAI) and other quality metrics to ensure high product quality and process improvement opportunities are identified
- Reviews and ensure all process, material, and procedural changes are in compliance to all QMS procedures and are based upon sound quality engineering principles
- Develops systems to identify, analyze, correct and prevent issues that may adversely affect product safety and performance
- Leads Material Review Board (MRB) activities and supports internal and external customers with a broad depth of quality related knowledge
- Provides Manufacturing systems expertise, knowledge, and leadership in support of production and testing
- Coordinates Quality Plan on new product development activities such as, but not limited to, design review active participation, capability studies, gage R&R, pilot runs, PQ/OQ support, gage fixturing designs and implementation.
- Daily focus on improving, implementing, and maintaining quality systems
- Records and evaluates test data. Using statistical quality control procedures prepare charts and write summaries about how well a product conforms to existing standards. More importantly, offer suggestions on how to modify existing quality standards and manufacturing procedures to improve quality and/or scrap reductions.
- Directs team members engaged in measuring and testing product and tabulating data concerning materials, product, or process quality and reliability
- Assists with calibration program such as, but not limited to, calibration scheduling, purchasing of new measuring equipment, maintenance of current and new equipment ensuring adherence to ISO standards. Lead calibration cost reduction and improvement initiatives.
- Leads and coordinates First Article Inspection Reports (FAIR) activities ensuring FAIR are completed in a timely manner. Maintains FAIR records; collaborates with NPD on FAIR statuses. Drives mitigation activities on FAIR concerns.
- Leads development of, and coordinates Control Plans creation required for NPD, Production, Purchasing, and ongoing production
- Assists in customer issues part investigation and reporting such as, but not limited to, detailed investigation, prepare reports, recommends resolutions, corrective and preventive actions
- Leads Material Review Board activities, including those for remote manufacturing facilities; ensuring proper trending, closure of issues and dispositions are appropriately addressed. Drive continuous improvement initiatives based on MRB data.
- Assists with training for production, engineering and QC personnel for necessary equipment measuring techniques
- Leads and provides expert advice in regards to Dimensional Metrology.
- Maintains measuring techniques documentation
- Assists in internal audit activities such as, but not limited to, scheduling, preparation, reporting and follow up
- Other Quality Assurance/Quality Control/RA functions QCE may participate in, but are not limited to: Reliability Testing, PPAP, Fault Report Maintenance, Continuous Improvement, Supplier Maintenance, Management Reviews
- Performs all other duties as assigned
EDUCATION & EXPERIENCE REQUIREMENTS
- BS in quality engineering or similar from an accredited college or university
- At least 6 years of related experience working in a regulated (FDA, ISO13485) medical device manufacturing environment
- Must have hands on experience in statistical analysis
- Proficient in use of SPC analysis tools, Microsoft productivity suite, and proven experience in tracking all data and activities in an Enterprise Resource Planning (ERP) environment maintaining all required records in electronic format
SKILLS & ABILITIES
- Must understand mechanical drawings (i.e. dimensions, tolerances, standards, etc.) and apply to the measurement and inspection of parts for dimensions, performance, and mechanical properties
- Must be able to use standard measuring/inspection devices (i.e. micrometer, digital scales, gauge pins, microscope, non-contact measuring scope, caliper, etc.)
- Excellent written and verbal communication skills including ability to communicate/present complex ideas and resolutions/plans in a group setting
- Demonstrated problem solving skills – Root cause Analysis / Problem Solving Methods (8-D, PDCA, DMAIC)
- Ability to effectively present information and respond to questions from groups of managers, customers and the general public.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Must be able to work both in a team environment and independently
- Strong understanding of ISO 9001:2000, FDA-GMP, 21 CFR 820 and ISO13485
WORKING CONDITIONS & PHYSICAL DEMANDS
Manufacturing Environment. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.
Meet Some of Nordson's Employees
Taking on new challenges in multiple markets worldwide, Madeline takes pleasure in designing, testing, and improving Nordson's expansive products and systems as an engineer.
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