- Nationally Recognized Manufacturer Making Mark on Medical Device Manufacturing
- Work under C Level Management to promote OEM/component manufacturing
About Our Client
My Client offers a full suite of design, development, process, and manufacturing services for single-use and single patient medical devices. They create OEM devices, components and packaging, from Innovation to Manufacturing. They have a portfolio with best-in-class operational excellence systems to improve patient outcomes for their clients.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Quality Engineer will
* Develops and documents quality plans for new and existing products.
* Analyzes quality control test results and provides feedback and interpretation to production management or staff.
* Supports manufacturing and engineering problem solving efforts on in-process and vendor related quality issues.
* Communicates quality control information to all relevant organizational departments, outside vendors and contractors.
* Investigates customer returns and complaints. Oversees development and implementation of corrective action measures to prevent re-occurrences.
* Implements procedures to assure that products comply with customer specifications.
* Coordinates, as needed, the administration of the defective material identification & disposition program; i.e., the PMDR & MRB program.
* Monitors & takes corrective/improvement action on key quality measurables; i.e., parts per million (PPM), repeat complaints.
* Performs or delegates the quality department functions defined in our APQP process.
* Provides training to manufacturing personnel to assist in the preparing definition and monitoring of quality requirements.
* Serves as the quality management representative, representing the quality management system to external organizations.
* Supports product development and transfer into production to ensure process capability exists and product requirements are understood.
* Participates in conducting both internal and vendor audits; including 2nd and 3rd party quality system audits.
* Supports purchasing in supplier performance measurement.
* Oversees and directs activities of quality department staff in support and maintenance of quality systems.
* Manages individual performance providing coaching, mentoring and performance feedback to ensure that plant objectives are achieved. Instructs and mentors quality staff in quality control and analytical procedures.
* Develops and implements quality training programs to train employees on the appropriate and necessary quality systems, techniques and methods including ISO 13485 and statistical methods.
* Produces reports regarding nonconformance of products or processes, daily production quality, root cause analyses and quality trends.
* Manages internal/external calibration of all required measurement devices, gauges and testing equipment.
The Successful Applicant
The Quality Engineer should have...
* Bachelor's degree or equivalent in quality, operations management or engineering related field.
* A minimum of 5 years experience in manufacturing with at least 2 years in a management capacity.
* Depending on site location, experience in an ISO environment and ISO 9000, compliance with TS16949 and PPAP procedure.
* Experience in Medical Device manufacturing required. * Demonstrated ability implementing "world-class" quality management practices to drive continuous improvement throughout the quality systems.
What's on Offer
The Quality Engineer will get in return...
- Competitive compensation and benefits
- 401k Matching Contribution
- High exposure to upper management with a lot of upwards mobility
- Employee Discounts from local business
- Relocation assistance IF NEEDED
Please reach out to Cameron Cyker with any questions. All qualified candidates can expect feedback within 48 hoursApply below today!