Job Title: Quality Engineer
Reports To: Quality Manager
FLSA Status: Exempt
Direct Reports: No

Position Summary:

Responsible for ensuring the highest level of Quality possible by adopting a Zero-Defect attitude towards Quality.  Embraces and utilizes the Quality Management system to drive compliance throughout the business site to ensure conformance to international standard, customer, and intercompany process/procedural requirements.  Adopts a disciplined approach to problem solving and looks for opportunities to eliminate Cause/Effects of issues in efforts to maximize gains.  Utilizes Corrective Action as the tool to respond to quality excursions and ensures CAR’s are effective in addressing root causes, verification, and validation of plans for complete closure.  Engages with other departments as well as senior management for addressing any area of concern in order to ensure product and system quality. Works with the QC inspection team to ensure proper inspection techniques/methods are being followed in accordance with established quality procedures and policies.  In partnership with QM develops/creates and implements quality procedures/policies that impact product Quality.  Possess the ability to quickly grasp new ideas and concepts and has a high level of motivation with ability to meet stringent deadlines.  Responsible for completing inspection as needed by company specifications/drawings.

Essential Functions/Responsibilities:

• Completion of First Article Inspection reports via AS9102 format of parts and assemblies to detailed drawings using a working knowledge of GD & T.
• Use of metrology skills with handheld measuring tools, CMM, and with surface plate layout ability preferred
• Create, adhere to, and ensure compliance with Quality System SOPs, product SOP’s, work instructions, and drawings.
• Utilize Failure Mode Effects Analysis (FMEA) to identify risks within process/product inputs/design characteristics and implement control plans to mitigate identified risks.
• IQ/OQ/PQ protocols, PPAPs, inspection criteria
• Identify and drive continuous improvement activities in support of product Quality and quality management system.
• Produce and implement proper controls, operator instructions and quality tools used to verify customer’s products at all phases within our process.
• Responsible for documenting/implementing sampling plans/techniques in support of product inspections per applicable industry standard and/or customer specifications.
• Responsible for adjusting sampling plans/techniques based on the outcome of inspection results (e.g., tightening of sampling, or loosening based on sound data analysis)
• Initiate product nonconformance investigations utilizing structured problem-solving techniques/methods to determine root cause and corrective and preventive actions.
• Preparation of investigative reports, failure analysis in response to reported issues, e.g., response to customer returns, complaints, MRB activity.
• Analyze/Report data to identify defect trends within product criteria e.g., MRB data, Nonconformance Report, customer complaints etc. Coordinate drive improvements based on pareto analysis principle. 80/20 rule
• Participate in MRB reviews and coordinate with other responsible team members for the proper disposition of product on appropriate forms and within system requirements.
• Communicate effectively and work directly with the tooling and manufacturing functions making sure adequate systems and inspection methods and tools are used throughout the plant for molding or assembling products.
• Utilize Minitab and other qualitative and statistical methods and tools to collect, summarize, analyze, interpret and communicate process capability and performance, including the use of key statistical process control (SPC) tools.
• Use engineering judgement to identify problem root causes, make and recommend changes in documentation or a process for Corrective or Preventative Action to prevent recurrence and provide continuous quality improvement.
• Perform audits as to meeting Quality System requirements, preferably to AS9100 and/or ISO 13485.
• Maintain compliance of the calibration program.
• Perform mentoring, education, and training of QA and manufacturing personnel.
• Utilize lean six sigma techniques and methodology to drive waste out of the processes in efforts to reduce lead times, process cycle time, TAKT time (touch labor) while maintaining quality performance.
• Mechanical aptitude and experience in assembly work, creation of standard work for assembly operations, a plus.
• Assume additional responsibilities as necessary at the discretion of QA Management.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements and work conditions, including physical demands, listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1. 1. Must have computer skills and familiarity with Word and Excel programs.
   2. Must have knowledge of SPC, ISO 9001 & 13485 system requirements.
   3. Ability to work with probability and statistics, and fundamentals of trigonometry.
   4. Must be capable of providing sound judgement, on multiple fronts, in an appropriate and professional manner with employees, customers, and suppliers.
   5. Proven track record of project management success

Education/Experience:

• Bachelor’s Degree in Engineering or related field.
• Four years of experience in related field.
• Experience with SPC, ISO 9001 & 13485 system requirements.
• Must be proficient in Word and Excel.
• Previous experience in quality/engineering.

Language Ability:

Ability to read, analyze, and interpret in English. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Math Ability:

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis.

Reasoning Ability:

Ability to solve practical problems and interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

1. Problem Solving (46-100%)
2. Making decisions (46-100%)
3. Supervising (16-45%)
4. Interpreting data (46-100%)
5. Organizing (46-100%)
6. Reading/Writing (46-100%)
7. Evaluating (46-100%)
8. Consulting (46-100%)
9. Presenting (46-100%)

Work Environment:

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts and is occasionally exposed to toxic or caustic chemicals. The noise level in the work environment is usually loud.

1. Indoor (46%-100%)
2. High Temperatures (16-45%)
3. Low Temperatures (16-45%)
4. Fumes (0-15%)
5. Loud Noises (0-15%)
6. Using oil/chemicals (0-15%)

Physical Demands:

1. Standing (46-100%)
2. Sitting (46-100%)
3. Lifting maximum of 30 lbs. (46-100%)
4. Carrying (46-100%)
5. Walking (46-100%)
6. Driving (16-45%)
7. Reaching/pulling/pushing (46-100)

Beacon MedTech Solutions is an Equal Employment Opportunity employer and does not discriminate in our hiring or employment practices.  All qualified applicants will receive consideration without regard to race, creed, color, religion, sex, national origin, age, disability, genetics, citizenship, military service, marital status, status with respect to public assistance, sexual orientation or any other protected class as defined by Federal or State law requirements.  We comply with all Federal and State laws specific to nondiscrimination.