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Job Description
Primary Responsibilities and Essential Job Functions:- Drive improvements to the quality system that ensures its suitability, adequacy and effectiveness.
- Provide operational support related to issue resolution, product quality/risk assessment and product disposition.
- Lead implementation of quality system processes which may include but are not limited to supplier management,internal audits, complaint handling, document control, corrective and preventative action, non-conformingmaterial and deviations.
- Provide facility quality support and representation in new product development, scale up, design transfer, and facility validation activities.
- Represent quality on core design change and new product development teams to ensure the design control process is being followed effectively and to create deliverables including batch records and control plans.
- Coordinate and complete Continuous Improvement initiatives.
- Provide training for the development of Quality Control Technicians/Analysts.
- Understand and ensure compliance with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations
- Provide support in internal, customer, supplier and regulatory audits.
- Create and provide quality metrics for management review.
- Approve process changes as defined by Quality system.
- Approve the release of product for shipment to customer.
- Release new product development projects to Operations for production.
Qualifications
- Bachelor’s degree in Engineering or technical related field.
- Three years relevant experience in Quality preferred.
- Knowledge of ISO 13485 and 21 CFR Part 820 preferred.
- Six Sigma Training is a plus.
- Experience handling multiple responsibilities with minimal direction.
- Strong written and verbal communication skills; strong presentation skills.
- Able to effectively work with various functions and levels within the organization.
- Up to 10% travel.
Additional Information
Who we are!- Our Story:
- We not only embrace change… we drive it.
- Our culture is innovative and collaborative - where bold ideas turn into action.
- We are committed to workplace diversity, both for employees and for the business.
- We are a force for good, embedded in industries and communities worldwide.
- We are challenging ourselves and others to reach higher and think bigger to improve the quality of all life.
- Structured learning and development
- Mentoring program
- Competitive total rewards
- Commitment to Sustainability
We look forward to receiving your application.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status or other protected status. EEOE/M/F/Vet/Disabled. All your information will be kept confidential according to EEO guidelines.
If you require accommodations to view or apply for a job, alternative methods are available to submit an application. Please contact 440.534.6080 or[emailprotected]to discuss reasonable accommodations.