Nolato GW is a part of the Nolato group. Nolato is a Swedish publicly listed group with operations in Europe, Asia and North America. We develop and manufacture products in polymer materials such as plastic, silicone and TPE. Nolato GW Plastics is a global leader in precision injection molding and contract manufacturing to the world’s most successful companies. Join an organization that is respected throughout the industry for its advanced technology, quality, and innovation – all the while enjoying the benefits of stable ownership, a collaborative culture, professional development, continuing education, global opportunities, and an exceptional benefits package.
JOB TITLE: Quality Assurance Manager
DEPARTMENT: Tucson Operations - Quality Engineering/Assurance
REPORTS TO: General Manager
An experienced quality leader to drive the center of excellence for GMP requirements in a Medical Device Contract Manufacturing environment.
Responsible for developing, implementing, and maintaining a plant-wide quality system that focuses on customer satisfaction, defect prevention, and continuous improvement utilizing six sigma techniques.
- Manage the site Quality Management System including assuming effective management reviews, complaint handling, CAPA system, change control, calibration.
- Maintenance, internal auditing and manufacturing support.
- Improve quality assurance systems plant-wide to achieve zero defects.
- Identify and resolve systemic quality problems at both plant and corporate levels through a reduction in variation in processes and components.
- Maintain and enhance plant level quality system performance metrics.
- Ensure site wide training is effective and that the plant operates within the required regulatory guidelines examining and testing plant-wide processes and products from a final product acceptance and compliance perspective.
- Responsible for the continued development GMP capability and maintenance of compliance to US FDA Quality System Regulation (QSR, Part 820).
- Coordinate ISO9000/TS16949/ISO13485 upgrade training, certification and maintenance.
- Ensure effective transfers of new products into production that meet all Quality requirements for the classification.
- Validation (IQ, OQ, PQ) execution and reporting, Risk assessment and change control.
- Effectively work with Engineering Managers and Advanced Quality Engineers to insure on-time Initial Sample Inspection Report (ISIR) and Production Part Approval Process (PPAP) validation.
- Assist in developing a robust APQP (Advanced Product Quality Planning) system that assures quality risks are identified and resolved prior to production manufacturing.
- Improve profitability through reduced internal scrap and customer returns.
- Assist in supporting company-wide lean manufacturing efforts.
- Successfully interface with key customers and prospects to improve quality and win new business.
- Effectively work with field-based quality personnel to reduce customer complaints and achieve superior customer satisfaction.
- Mentor, train, and closely work with plant based Quality Engineers, inspectors and technicians to foster team work and communicate departmental priorities.
- Lead root cause investigation and champion the company’s corrective action system.
- Lead MRB activity.
- Perform process audits on the manufacturing floor.
- Plan, manage, and drive the internal audit program within the plant.
- Awareness and compliance to ISO 14000 requirements per company policies and procedures.
- Bachelor Degree (preferably in a technical discipline) or equivalent related work experience required.
- Minimum of 5-10 years quality assurance or quality engineering supervisory experience in an FDA-registered facility for medical device manufacturing.
- Requires thorough knowledge of cGMP’s Quality System Regulation (QSR) experience for medical device manufacturing.
- FDA audit experience with successful outcomes.
- Knowledge of the Medical Device GMP regulations and their appropriate application is needed to assure compliance with regards to manufacturing problems.
- Plastic injection molding experience desirable.
- Certified Quality Engineer, Certified Lead Auditor, and six-sigma black belt desirable.
- Excellent negotiation, presentation, meeting facilitation, and organizational skills.
- Strong customer relationship building skills.
- Strong “hands on” analytical problem solving abilities.
- Excellent written and oral communication skills.