Quality Engineer (ISO 9001, 13485)

Balda-C-Brewer; New York (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Balda-C-Brewer is seeking a Quality Engineer (ISO 9001, 13485) in Ontario, CA. This full-time professional role supports the Quality Management System, product realization, and manufacturing process controls with cross-functional collaboration.

You will develop quality plans, control plans, and procedures, and lead validations including statistical analysis, audits, and CAPA/NCR processes to ensure regulatory compliance and product quality.

Qualifications

• Minimum 5 years in quality engineering or QA leadership.
• Experience with ISO 9001 and ISO 13485 environments.
• Familiar with FDA QSR or medical device regulations.

Responsibilities

• Develop quality plans, control plans, and procedures for new products.
• Lead validations and statistical analyses for process controls.
• Prepare and audit quality systems, CAPA and NCR processes.
• Collaborate with cross-functional teams across Quality, Engineering, and Operations.
• Investigate customer complaints and drive corrective actions.

Skills

Quality engineering

ISO 9001

ISO 13485

Statistical analysis

PC-DMIS

Minitab

Caliper / Micrometer

GD&T reading

Education

ISO 9001 / ISO 13485 training

ASQ CQE / CQA / CQM

Bachelor's in Engineering or Quality

Tools

PC-DMIS

Minitab

Excel

MS Access

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Engineer (ISO 9001, 13485)

Full Time Professional Ontario, CA, US

22 days ago Requisition ID: 1119

Salary Range: $90,000.00 To $130,000.00 Annually

Quality Engineer supports all aspects of the Quality Management System, Product Realization and Manufacturing Process Controls. Working with cross functional partners, defines and generates quality control plans, production process controls and procedures. Leads and supports validations including statistical analysis. Engages with customers to address quality issues and define acceptance criteria/attributes.

Essential Job Functions and Responsibilities:

• Support the development and manufacturing of medical devices in conformance with applicable ISO 13485 requirements. Responsible for quality planning of all new development programs and design transfers to production.
• Ensure policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
• Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, Engineering, and Operations.
• Collaborate with Program Managers, Process Engineers, and/or Validation Engineers to execute process and equipment qualifications.
• Problem Resolution: identification, data collection and trend analysis, reporting, and initiation of corrective and/or preventive action as well as reporting out of Key Metrics.
• Identify opportunities and implement solutions to drive continuous improvement in performance metrics.
• Investigate customer complaints, corrective actions and trending to drive improvements. * Plan and perform regular audits of quality system and drive system improvements through the Internal Audit and Quality Event Management (CAPA, NCR, Complaint etc.)
• Monitoring and improvement of SPC systems, sampling plans and statistical methods. * Back-up and or perform to Head of Site Quality/Supervisor Representative, as assigned.
• Plan, prepare, and execute Internal Audits, as assigned.
• Participate in Material Review Board and/or Change Control Board as QA representative.
• Utilize tools, gauges and other inspection equipment to obtain product specification data * Expert in utilizing hand measurement tools (Caliper, Micrometer, Ruler, Gage Blocks, height gage, etc.).
• High Proficiency with PCDMIS inspection software utilizing CMM’s: Brown, Sharpe, Hexagon, Smart scope.
• Expert with utilizing ANSI Sampling Plans, IQMS, Minitab, Excel and Microsoft Word
• High Proficiency in material analysis (i.e. FTIR, Melt Flow Testing, etc.)
• Ability to read and decipher blueprints * Proficient in metrology and calibration.
• Working knowledge of statistical methods for manufacturing.
• Proficient in Geometric Dimensioning and Tolerancing (ANSI Y-14.5)

Requirements:

• Minimum Education: five (5) years’ experience in a similar field. Working knowledge in problem solving methodologies. Excellent oral and written communication skills.
• Minimum Experience: At least two (2) year experience in a supervision and/or management role. Demonstrated experience to lead teams and projects. Good organizational skills. Previous experience in plastic injection molding related environment.
• Demonstrated experience to lead teams and projects. Good organizational skills. Previous experience in plastic injection molding related environment.
• Working in a medical device or other FDA regulated industry. Comprehensive understanding of ISO 9001, ISO 13485, JPAL MHLW Ordinance 169, and/or FDA QSR regulatory requirements. Computer literate with working knowledge of MS Word, Excel, and Access.
• Desired candidate will have prior work history in MSA, SPC, Mini-tab, Infinity, sterilization, & clean room environment. *Knowledge, Skills, and Abilities
• A working knowledge of FDA cGMP, ISO13485 requirements
• A working knowledge of medical device manufacturing quality systems.
• Working knowledge of Statistical Methods used in manufacturing. * PC-DMIS knowledge a plus.

Education and/or Experience:

• 3-7 Years in Quality Engineering in manufacturing and/or quality assurance.
• Training in applicable ISO 9001, ISO 13485.
• Experience using Minitab.
• Proficient in metrology and calibration standards.
• Proficient in Quality Audit concepts.
• Certifications such as ASQ CQE, CQA, CQM
• Warehouse areas (limited)
• Will be required to perform other duties as requested, directed or assigned.