Quality Engineer

Quality Engineer Job Highlights

Company Profile

MW Components is a precision component and product manufacturer. The company focuses on accelerating the entire process of delivering custom, stock, and standard parts to virtually any volume and against demanding deadlines.

Job Profile

The company (Paragon Medical, a division of MW Industries) is seeking a Quality Engineer who will be responsible for meeting customer requirements for the manufacturing of surgical instruments and implants or instrument delivery systems from receiving raw materials to the shipping of finished goods.

Supports and enforces the development of internal systems and procedures to meet ISO standards and FDA quality system regulations.

Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process.

Specifies and implements new inspection equipment and instructs others in its proper use.

Supports and implements systems in the areas of SPC, advanced quality, and design/development.

Educational Qualification

• Applicants should have a Bachelor’s Degree in Engineering or a related field from a college or university

Work Experience

• Possess a minimum of 2 years of experience with tight tolerance measurement systems in machining applications, blueprint reading, GD&T, and a working knowledge of short-run process control methods, DOE, ISO standards, and FDA quality system regulations.
• Willing to consider relevant experience in combination with professional certificates in Quality such as CQE or CMQE/OE.
• Previous medical device experience preferred.

Duties/Responsibilities

• Assists in the development and implementation of systems and processes that foster continuous improvement for product development or manufacturing.
• Be able to meet the requirements of the vision screening test (eye chart).
• Be able to meet the visual acuity requirements (shades of color and color blindness).
• Completes the implementation and performance of gage R&R, process capability studies, design of experiments, and summaries as required to improve quality and provide required deliverables to customers.
• Creates and supports ECNs and SCRs (product).
• Design inspection/validation steps to be taken by operations at the point of manufacture and integrate these steps into the manufacturing instructions.
• Ensures processes are released with the use of SPC where applicable or promote the utilization of SPC.
• Investigates deviations, OOS, complaints, returns, recalls, and field alerts.
• May authorize, initiate or approve product and process changes.
• May lead or verify the effectiveness of corrective and preventive actions (CAPAs).
• May liaise directly with customer representatives.
• Provide day-to-day oversight of quality including batch testing, inspection, calibration, environmental monitoring, qualification, document review, etc.
• Provides SPC and ongoing monitoring of SPC.
• Responsible for ensuring cell processes are correctly base-lined & controlled. Known variability is to be accounted for through the selection and frequency of inspection, sampling plans, or implementation of SPC.
• Responsible to create, implement and improve quality systems and procedures for meeting ISO 13485, FDA, and customer quality system requirements.
• Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements.
• Supports both internal and external audits of all corporate quality systems and demonstrates compliance through objective evidence.
• Supports the Material Review Board (MRB) for internal non-conformances and customer returns.
• Verify that all production procedures have been followed and records such as Device Master Records and Device History Records are maintained per FDA & customer requirements and NN Life Science requirements.
• Work in conjunction with Cell Leaders to ensure CNC Machinists are knowledgeable and competent in the use and care of sensitive measuring equipment and related requirements such as calibration, recording of data, expected variability, etc.

Skills/Knowledge/Abilities

• Demonstrates problem-solving skills, applying effective, data-driven, mistake-proofing concepts
• Excellent customer teaming and interpersonal aptitude
• Excellent follow-up skills required
• Excellent organizational skills and attention to detail required
• Able to work with limited supervision and actively participate in a team-oriented, continuous improvement, manufacturing environment
• Strong computer skills including excellent Word, Excel, PowerPoint, and Minitab skills
• Strong project management skills required
• Strong written and verbal communication skills

Physical Demands

• Occasionally required throughout the workday to stand; walk; sit; use hands to handle objects, tools, or controls; reach with hands and arms; balance; stoop, kneel, crouch; talk or hear.
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to see print in various sizes and formats.
• May be required to climb stairs.
• Must regularly be able to pull and push up to 25 pounds and occasionally lift up to 50 pounds.

Work Environment

• Work performed in a production environment
• Exposed to weather conditions prevalent at the time (for maintenance/receiving only)
• The noise level in the work environment is usually moderate to high, in some areas

Employer’s Statement

MW Components is an Equal Opportunity Employer. The company considers all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws.