Quality Manager - NA Winston Screen Test

Avery DennisonSB•Mentor, OH

14h

About The Position

Avery Dennison (NYSE: AVY) is a global leader in labeling and packaging materials and solutions. Each distinctive product and technological leap forward is brought to light in an energizing environment where teamwork and curiosity thrive. Looking for a collaborative culture where bold ideas turn into action? Then this is the place for you! With over 25,000 employees in more than 50 countries, we're inspired by the art of the possible, and motivated to continuously improve.

Requirements

Bachelor’s degree in Engineering or scientific related field.
A minimum of 4 years of experience in the medical device or pharmaceutical industry with at least 3 years of experience in regulatory compliance and quality systems.
Detailed knowledge of ISO 13485 and 21CFR Part 820.
Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) and/or Certified Manager of Quality/Operational Excellence (CMQ/OE).
Experience balancing 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.
Willing and able to travel up to 25%.

Responsibilities

Drive improvements to the quality system that ensures its suitability, adequacy, and effectiveness.
Understand and ensure compliance with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations.
Provide operational support related to issue resolution, product quality/risk assessment, and product disposition.
Assist in the investigation of non-conformances as the need arises.
Conduct, coordinate and review investigation of product complaints and assignment of root cause determinations when required.
Determines if complaints require regulatory affairs involvement for adverse event evaluation.
Provide QA support in the review and approval of plant related validation protocols, reports, and change requests.
Provide facility quality support and representation in new product development, scale up, design transfer, and facility validation activities.
Represent quality and/or regulatory on core design change and new product development teams to ensure the design control process is followed effectively.
Participate in the ISO 13485 certification process and regulatory inspection.
Provide support in customer, supplier, and regulatory audits.
Maintain quality systems and provide support for specific sections of the quality system as assigned.
Develop and conduct training related to quality system and regulatory requirements.
Develop quality SOPs to ensure compliance.
Track and trend key Quality metrics.
Supervise assigned direct reports per organizational charts.
Perform other job duties as assigned.
Release new product development projects to Operations for production.
Approve process changes as defined by Quality system.
Approve or supervise those approving the release of product for shipment to customer.