Quality Manager - Medical Device

Johnson Electric Vandalia , OH 45377

Posted 1 week ago

The Quality Manager is a manufacturing quality specialist responsible for developing and managing the Quality Management System; oversees Quality inspection of processes and products; assures and certifies product compliance. Maintains quality system conformance, quality data collection/reporting, Field Return system/analysis, and Corrective and Preventive Action system. A key part of the role is to ensure 100% quality product is manufactured on a first time basis through process control and effective production techniques. This requires a highly integrated and hands on approach with engineering and production operations.

Responsibilities:

Establishes quality standards and metrics for new processes with Engineering and Operations, defining methods & standards to improve product quality and productivity. Active in Genba Kaizan activities company wide.

Coordinates/manages the scheduling and control of inspection activities and enforcement requirements for raw materials, components, product and package specifications and regulatory agencies.

Determines overall plant product quality by coordinating the implementation of methods and procedures for inspecting, testing and evaluation of products and production equipment.

Maintains compliance with all documented Quality Policies and Objectives; assists in obtaining and maintaining required Quality certifications.

Assists in resolving quality problems by driving efforts of quality, engineering, and operations personnel to identify root causes of problems and appropriate corrective and preventive action.

Coordinates field return/ failure analysis system, calibration, change control and material review board.

Act as front line for customer concerns on quality issues or related technical questions.

Establishes and maintains effective inspection and tests to ensure product quality/reliability.

Ensure compliance with all corporate directives or initiatives for quality, control processes etc. Achieve compliance. Act as instructor, facilitator, coordinator and auditor to ensure implementation is effective.

Coordinates quality data collection and reporting system.

Requirements

Basic Qualifications:

3+ Years of experience with FDA Medical Device Manufacturing (ISO 13485)

Bachelors degree in Engineering or Science based discipline

6+ Years of experience working in Quality

Eligible to work in the United States without sponsorship

Preferred Qualifications:

Solid knowledge of Design Controls, Quality Control and assurance practices.

Internal Audit experience

Change Control and Supplier Management experience

Knowledge and Practical implementation of ISO 9001 and ISO 13485

Prior practical experience with 6 Sigma, SPC, Cpk, AQPQ, PPAP

RoHS/REACH/SVHC/IMDS reporting is desired

Local candidate

Benefits

Benefits:

JE offers talented employees exceptional opportunities to learn and grow professionally with rewarding careers. We offer a competitive benefits package including medical, dental, prescription plan, vision, disability coverage, life insurance coverage, 401K match, and holiday/vacation benefits.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Quality Engineer

Johnson Electric

Posted 1 week ago

VIEW JOBS 10/18/2020 12:00:00 AM 2021-01-16T00:00 <p>Johnson Electric is now recruiting for a <strong>Quality Engineer in Vandalia, OH.</strong> Johnson Electric offers talented employees exceptional opportunities to learn and grow professionally with rewarding careers. We offer a competitive benefits package including medical, dental, prescription plan, vision, disability coverage, life insurance coverage, 401K match, and holiday/vacation benefits.</p> <p>The Quality Engineer for Vandalia, OH., will support all aspects of the Quality Assurance (QA) program within the Quality Management System (QMS). The QE reports to the Q&amp;R Manager. This position will lead all customer and third party quality audits. Participate in Design Project Teams as a QE/QA Representative to ensure that input requirements (internal, external, and customer) are clearly defined, risk assessment is performed, output meets input requirements, and objective evidence clearly supports conclusions. Perform quality related design control activities as assigned by Design Project Team. Partner with production during Design Transfer phase to ensure that products and processes meet all quality requirements.</p> <p><strong>Responsibilities:</strong></p> <ul> <li>Lead QE function within new product teams to ensure customer and regulatory requirements are met along the product development cycle.</li> <li>Develop and implement quality system per ISO 9001, FDA 21 CFR820 and customer requirements. Create production, calibration, inspection, and maintenance procedures as required. </li> <li>Use Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), Fish Bone Diagram, Risk Analysis, or other appropriate quality tools to define and manage risk or identify root cause of failure.</li> <li>Lead the resolution of quality issues related to non-conformance reports, customer complaints, regulatory actions, etc. Support CAPA investigations and related corrective and preventive actions.</li> <li>Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ). Develop, review and improve inspection plans, standard work sheet and product drawings.</li> <li>Lead continuous improvement activities. Support Kaizen activities and re-work/scrap reduction.</li> </ul><p><strong>Requirements</strong></p><p><strong>Basic Qualifications:</strong><br></p><p>Minimum of 4 years’ experience as a QE (or equivalent)<br></p><p>Eligible to work in the United States without Sponsorship</p> <p><strong>Preferred Qualifications:</strong></p> <ul> <li>Bachelor ‘s Degree in Engineering or Physics</li> <li>Current ASQ CQE or CQE in progress</li> <li>Experience in the practical application of statistical process control, quality techniques and FDA Quality System Regulation and ISO 9001, ISO 13485, TS16949 or equivalent</li> <li>General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization required</li> <li>Local candidate preferred</li> </ul><p><br></p><p>Johnson Electric is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.</p><p><strong>Benefits</strong></p><p>JE offers talented employees exceptional opportunities to learn and grow professionally with rewarding careers. We offer a competitive benefits package including medical, dental, prescription plan, vision, disability coverage, life insurance coverage, 401K match, and holiday/vacation benefits.</p> <p><strong>About Us:</strong></p> <p>Johnson Electric is a global leader in motion products, control systems and flexible interconnects. We serve a broad range of industries including automotive, building automation and security, business machines, defense and aerospace, food and beverage, home technologies, HVAC, industrial equipment, medical devices, personal care, power equipment and power tools.</p> <p>Established in 1959, Johnson Electric ships its products to more than 30 countries for use in hundreds of different product applications. Innovation and product design centers are located in Hong Kong, China, Switzerland, Germany, Italy, Israel, France, Canada, UK and USA. We employ more than 40,000 employees and subcontract workers in over 23 countries.</p> Johnson Electric Vandalia OH

Quality Manager - Medical Device

Johnson Electric