In this position you will perform metrology utilizing various metrology equipment. You will also develop, implement, and evaluate quality processes, procedures, controls, metrics, and statistical techniques; analyzes process capability, standards and recommends improvements to ensure quality, cost, and efficiency goals and requirements are met; recommend revision of specifications when indicated; and formulates or helps formulate quality policies and procedures. Utilizes various quality tools and software applications to aid in the above. Attention to detail and organizational skills critical.

Essential Job Duties and Responsibilities:

• Participate in activities concerning the development, implementation and maintenance of quality standards for all programs.
• Develop validation protocols, with customer input, monitor execution, and develop completion reports for approval.
• Responsible for First Article Inspection, pFMEA and Risk Analysis, Capability Studies, and customer driven requirements for device programs, GR&R.
• Corrective Actions and Supplier Corrective Actions.
• Inspection of fixture design
• Quality Systems and Analysis:
  • Reviews new projects and sees to the following as applicable:
  • Identification of critical variables and attributes;
  • First article sampling and reporting;
  • Develops Inspection Instructions/Techniques
  • Statistical analysis if required;
  • SPC dimensional monitoring for production;
  • Identification of resources needed to meet or assess required quality;
  • Preparation for quality assurance of initial trial and subsequent production;
  • Identifies needed holding/locating devices for Measurement Analysis and Designs.
• Reviews existing production:
  • Applies, utilizes and updates SPC;
  • Identifies opportunities for improvement to process and product;
  • Provides applicable training;
  • Utilizes the CAPA and NCR systems to facilitate improvements.
  • Performs various analyses as assigned:
  • Identifies, quantifies, and monitors product and process quality;
  • Measures various other performance indicators;
• Reporting:
  • Prepares various reports as assigned.
  • Interfaces with customers:
  • Quality Planning, Non-Conforming Materials, Continuous Improvement, Weekly Meetings, Corrective/Preventive Actions, Audit Activities, etc.
  • Supports the ISO 13485 Business Management System through Internal Auditing.
  • Continuous Improvement:
  • Conducts investigation, root cause analysis and corrective actions;
  • Coordinates implementation of product and process improvements;
  • Monitors and expedites the closure of corrective/preventive actions resulting from customer complaints, safety issues, management review, non-conforming product and staff generated.
  • Conducts training as assigned;
  • Participates and Leads Lean Projects for waste elimination
• Standards:
  • Develops, maintains and updates Procedures, Work Instructions, and Forms
  • Perform other duties as assigned.

Essential Qualifications:

• Bachelor’s Degree in technical related field preferred.
• Minimum of 3 years’ experience within Quality Assurance preferred.
• Excellent planning, leadership, and client relationship skills
• Excellent interpersonal communication and writing skills
• ASQ, CQT/CQE
• CMM/MicroVu Programming Experience
• Solidworks Modeling Software Experience
• Gage R&R, CpK/PpK studies,
• IQ, OQ, PQ validation/qualifications, DoE analysis… etc.
• Injection molding background
• Medical Device manufacturer background
• Experience using Minitab Software for SPC, DOE, etc.
• Experience with the following:
  • Various metrology equipment.
  • Microsoft Office suite
  • Statistical process control
  • Ability to read, write and speak English

Desirable Qualifications:

• Experience within the medical device industry.
• Previous experience with lean manufacturing concepts.

Physical Requirements and Environmental Conditions:

• Medium work: Exerting up to 50 pounds of force occasionally and/or a negligible amount of force constantly to move objects.
• Ability to work for extended periods sitting and looking at computer while completing repetitive motions to include substantial movements (motions) of the wrists, hands, and/or fingers.
• Close visual acuity to perform an activity such as preparing and analyzing data and figures; reviewing detailed information; viewing a computer terminal; and expansive reading.
• The ability to manage a number of projects at one time with frequent interruptions and tight deadlines.

We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.

Salary Range: $70,000 - $120,000 / year

#IND

#LI-SS1