- Participate/lead both internal and external audits.
- Lead and consult on Quality related continuous improvement projects.
- Create and update programs, policies and procedures that generate significant improvement in meeting customer and ISO requirements.
- Partners with team members to support internal/external audit processing including identifying and training internal auditors.
- Communicates CPC audit responses to customers.
- Tracks customer audit findings and works cross functionally to close findings according to CPC time commitments.
- Establish audit metrics and reporting to management.
- Maintains effective and appropriate relationships with key internal stakeholders.
- Keeps current in the field with external or internal education and training.
- Investigates and dispositions non-conforming products identified in manufacturing.
- Leads/assists in continuous improvement projects supporting manufacturing.
- Provides support to manufacturing with regards to quality concerns related to product.
- Be a Quality advocate internally and externally.
- Adheres to all safety regulations.
- Demonstrates support of CPC core values.
- Performs other job duties as assigned to meet business needs.
- High School Diploma.
- A minimum of (1) years in the medical device, biopharmaceutical or other highly regulated industries.
- Experience working within a manufacturing organization.
- Understanding of up-to-date Quality requirements.
- Passion for improvement and drive for change to meet customer needs.
- Exceptional analytical skill - ability to manage complex data including finance.
- Strong working knowledge ISO 9001 and ISO 13485.
- Excellent communication and influence skills.
- Three (3) years of progressively responsible positions in Quality Assurance.
- Experience with Windchill software
- Experience in auditing to ISO 9001 and ISO 13485.
- ISO 9001 and/or 13485 Certified Auditor
- ASQ participation and certification(s)
- Oracle or similar ERP software experience
- Up to 5%, domestically
- Must frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision. While performing the duties of this job, sitting is regularly required; use of hands and fingers, and talk or hear. Reaching is frequently required to with hands and arms. Occasionally required to stand, walk, and/or stoop.
- The noise level in the work environment is usually moderate.
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Associate Quality Systems Specialist - Arden Hills, United States - Dover Corporation
Description
Colder Products Company (CPC) is the leading provider of quick disconnect couplings, fittings and connectors for plastic tubing. At CPC, we believe that fluid handling should be safe and easy. We engineer our connection solutions to improve the overall functionality and design of equipment and processes for the life sciences, industrial, and chemical handling markets. Special features of our products include precise hose barbs for superior grip, built-in shutoff valves for preventing spills, and easy-to-use, push-button thumb latches for quick connecting and disconnecting. CPC is a Dover company based in St. Paul with global offices and operations in Europe and Asia.
Job Summary
Do you want to share your passion for collaboration and dedication to customers? Are you looking for your next challenge? Join us in partnering with our customers to create the best connections in the world.
This is an amazing opportunity to contribute to a growing organization. Your role as a Associate Quality Systems Specialist will allow you to serve staff and leaders and help provide creative solutions to drive CPC's short- and long-term goals. You'll join a creative and passionate team of individuals. This role offers plenty of opportunities to grow your skills and expand your knowledge
Essential Job Responsibilities
Required Job Qualifications
Preferred Job Qualifications
Travel:
Physical Demands:
Work Environment:
CPC Culture
Here are CPC, we are committed to respecting and valuing people, collaborating, and having high ethical standards. We have a passion for creating the best connections in the world.
Mentorship & Career Growth
Our team is dedicated to supporting and empowering new team members. Our team has a wide range of experience levels and tenures. We are focused on building an environment that supports knowledge-sharing and mentorship.
Work/Life Balance
Our team puts a high value on work-life balance. Finding the right balance between your personal and professional life is important. We offer a Monday-Friday schedule. Our business hours are from 8am-4:30pm. We also provide paid holidays and PTO.
Work Arrangement : Onsite
We consider several job-related, non-discriminatory factors when determining the pay rate for a position, including, but not limited to, the position's responsibilities, a candidate's work experience, a candidate's education/training, the position's location, and the key skills needed for the position. Pay is one of the Total Rewards that we provide to compensate and recognize employees for their work.
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other factors prohibited by law.
