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. 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 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!The Quality Systems Specialist is responsible for participating in the management, governance, and execution of Quality Management sub-systems. Specifically, the person will be required to interact and collaborate with cross functional team members to promote and drive Quality Systems compliance regarding CAPA, cleanrooms, quality systems improvements, support customer requests for information related to the business and Quality Management System, and internal/external audits. Additionally, this role will support specific quality improvement projects as required. The individual filling this role is expected to apply problem solving and interpersonal skills and be able to influence and drive results. This position will work closely with other CPC Quality leaders to develop a world class Quality organization.
Job Responsibilities - CAPA process owner
- Participate in CAPA Review Board meetings and take lead as required
- Partners with team members to support Root Cause analysis to CAPA process
- Monitor CAPA metrics
- Participate/lead both internal and external audits
- Define and communicate responses to both internal and external audits
- Manage and track completion of responses to both internal and external audits
- Keeps current in the field with external or internal education and training
- Support management review process by preparing presentation material and scribing notes
- Identifies and implements improvements to the quality management system
- Supports customers through the completion of customer surveys and providing supporting evidence
- Supports processing document change orders and manages controlled documents
- Support of continuous improvement projects associated with CPCs cleanrooms
- 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
Qualifications - Bachelor's degree in engineering or related technical/ life science field. o 5 years equivalent business experience.
- A minimum of three (3) years of progressively responsible positions in Quality Assurance.
- 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 ISO9001 and ISO13485.
- Excellent communication and influence skills.
- Prefer disciplines in auditing, root cause analysis, technical writing, or similar.
Preferred Qualifications - Experience with Windchill software.
- ISO13485 Certified Auditor.
- ASQ participation and certification(s).
- Oracle or similar ERP software experience.
Travel Requirements Physical Demands - Must frequently lift and/or move 10 up to a maximum of 30 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 with hands and arms. Occasionally required to stand, walk, and/or stoop.
Work Environment - The noise level in the work environment is usually moderate.
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. We also provide paid holidays and PTO.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.#LI-LM1Job Segment: Technical Writer, CAPA, Quality Manager, QA, Quality, Technology, Management