FORM Document NumberPRM03-02

Job DescriptionRev. 0

Effective: 04/25/18Status: Released

Page 1 of 4

Job Title: Quality Engineer Reports To: Quality DirectorFLSA Status: Exempt Department: QualityEEO: Professional Date Revised: February 2018

Summary: The Sr. Quality Engineer position is responsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying statistical tools and working experiences. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a team atmosphere. Provides support and leadership to Quality Control team/department. Responsible for assuring products conformity to established requirements and standards through appropriate audit, inspection, and testing activities. Interacts with different functional departments, suppliers, and customers.

Essential Duties and Responsibilities, but are not limited to the following:Plan and Lead projects

Plan and manage all process validation projects and customers related PPAP, FAI, V&V, DVT projects.

Manages all customer related change request from initiating to implementation with partnership from Engineering and Operations.

Responsible for Quality function activities during the pre-production process including working with Quality Technician, Engineering, and customers on method of inspections, development of inspection sheets and ensure product/ process conformity to customer specifications.

Quality Assurance Responsibilities Provide technical expertise in the Quality arena to Manufacturing team and Engineering team as

needed, including but not limited to method of inspections, gaging selection, validation requirement, regulation requirement and processing of inspection data.

Represent Quality function in the board talks, Gemba walks, and communicate issues, findings, solutions to respective team members.

Responsible for the NCR, CAPA and Customer Complaint processes to ensure effective closures, and accurate documenting of these items.

Responsible for the Quality portion of the SOP creation/ updating process to ensure completeness, accuracy of Inspection Sheets and overall SOP package.

Measure and Report Quality Metrics at plant levelo Track all Quality and Delivery datao Create and presenting Monthly Quality Metrics at Plant level.

Manage and support the quality inspectors to ensure that products and processes comply with the relevant requirements of the quality management system.

Provide technical support to the inspection process techniques Ensure that all of the required in process inspections are performed and performed correctly. Provide support to Quality System improvement activities including

FORM Document NumberPRM03-02

Job DescriptionRev. 0

Effective: 04/25/18Status: Released

Page 2 of 4

Continuous Improvements Supporting continuous improvement projects with knowledge of the various quality improvement

processes (5S, Kaizen Lean methods, etc.), and statistically analysis utilize IQS, Minitab, and other Quality tools.

Provide recommendations to the plant management for improvement projects.

Supervisory Responsibilities: This position does not have supervisory responsibilities but needs to interact and communicate effectively and on time, with other employees and management to inform matters of importance.

Core Competencies:

1. Company Ambassadorship 2. Integrity, Ethics, Confidentiality3. Quality Oriented4. Customer Focus5. Cost Conscious6. Collaboration/Teamwork7. Creativity and Innovation8. Initiative/Adaptability9. Learning Orientation

Job Competencies: To perform the job successfully, an individual should demonstrate the following competencies:

1. Problem solving and decision-making skills2. Results Oriented and capable of identifying areas for improvement and new opportunities3. Time Management Skills to ensure that all projects are completed successfully and on time4. Excellent communication, interpersonal relations and negotiations skills5. Able to deliver customer presentation, discuss professionally quotes and proposal with customers.6. Continually evaluates results from these defined responsibilities and identifies improvement areas

and opportunities.7. Prepares special reports by collecting, analyzing, and summarizing information and trends.8. Keeps management and employees informed of all matters of importance and initiates or

recommends appropriate action9. Maintains objectivity and independence in actions which are in the best interest of the corporation

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.

Education and/or Experience: Bachelor’s degree in engineering or equivalent related 5 years of experience; or equivalent

combination of education and experience At least three (3) years in quality position in manufacturing environment, experience in a metal

manufacturing work environment preferred

FORM Document NumberPRM03-02

Job DescriptionRev. 0

Effective: 04/25/18Status: Released

Page 3 of 4

Other Qualifications: Excellent Computer Skills in Word, Excel, Power Point Strong attention to detail and numerical accuracy Ability to perform data entry of information fast and error free Ability to work effectively with all levels of the organization and influence teams to exceed

expectations Excellent written and verbal communication skills Knowledge of GMP and medical components and devices Skilled in the use and interpretation of SPC

Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Individuals may need to sit or stand as needed. The position may require walking primarily on a level surface for periodic periods throughout the day. The employee may reach above shoulder heights or below the waist or lift as required to file documents or store materials throughout the workday. Proper lifting techniques are required. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The performance of this position may occasionally require exposure to the manufacturing areas that may require the use of personal protective equipment such as safety glasses and hearing protection. For the most part the employee will be exposed to ambient room temperatures, lighting and traditional office equipment as found in a typical office environment.

Consequences of Improper Performance:Progressive disciplinary actions will be applied

Employee’s signature evidences the employee read and received a copy of this Job Description. Job description is reviewed as part of New Hired Orientation. Copy of the signed Job Description must be kept on the Employee’s File at Human Resources Department.

Employee’s Name

Employee’s Signature

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