Quality Manager II, Medical BU Job at Printpack Inc
The B.U. Quality Manager is responsible for the overall direction, coordination, and evaluation of the quality system and ISO 13485 in both of our plants (Tijuana and North Carolina). He/she will also be responsible for conducting gap analysis of our QMS and, together with the local quality managers and plant managers, implement actions to close those gaps and make the overall QMS better for our customers.
Job Responsibilities:
- Business Unit Management Representative for ISO 13485 Management System
- QMS structure knowledge and proven QMS GAP analysis experience
- Internal companywide audit team member & Medical BU representative
- Work with Product Development to develop functional product specifications prior to new product commercialization by conducting capability studies on both new and existing products.
- Maintain customer specifications and changes.
- Interact with manufacturing associates to ensure quality procedures are clear and understood and assist production management in ensuring that quality procedures are followed.
- Support continuous improvement efforts and implementation of Printpack Performance System.
- Interact with external raw material suppliers
- Interact with customers and visit as necessary to build relationships, to respond to complaints and support audit activity
- Aligns quality cultural expectations with local plant managers, engineering teams, and PPS program fundamentals
- Leads department-wide talent and succession planning activities to support business growth
- Responsible for all business unit shipped product, independent of the manufacturing facility
- Represents business unit on corporate functional projects and development programs
Knowledge and Experience Desired:
- CAPA process management, improvement, and execution
- Leading, managing, and supporting customer and ISO 13485 facility audits
- Supplier quality development practices, supplier audits, CAPA remediation activities, etc.
- Process/ product qualification and validation practices, change control process management
- Overall quality methodology and cultural transformation to a data-driven quality mindset
Minimum required qualifications:
- Bachelor’s degree in lean, quality, or engineering disciplines
- At least 7 years of quality experience in an operations environment
- At least 4 years of supervisory/leadership experience
- Willingness to travel up to 50%
- Training in statistical quality control methods
Preferred Skills & Qualifications:
- Experience in highly regulated medical/ pharma – ISO 13485 environment
- Ability to develop and drive the strategic direction of overall business unit quality direction
Printpack is proudly an equal-opportunity employer. We are committed to creating an inclusive environment. Embracing diversity enhances our work culture and is vital to our success. We do not discriminate based on race, color, religion, sex (including pregnancy), national origin, gender identity, sexual orientation, marital/parental status, genetic information, age, national origin, ancestry, ethnicity, disability, marital status, military or veteran status or affiliation, or any other characteristic protected under applicable law.
Know Your Rights: Workplace Discrimination is Illegal
Conozca sus Derechos: La Discriminación en el Lugar de Trabajo es Ilegal
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Printpack is committed to helping individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you need a reasonable accommodation to assist you with your application for employment or job search, please get in touch with us by sending an email to
CorpRecruiting@Printpack.com
. Please include in your email a brief description of the accommodation you are requesting and the position for which you are interested in applying.
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