Quality Manager

Job Title: Quality Manager

Company: Relucent Plastics Solutions

Are you ready to embark on a career that combines innovation, integrity, and a commitment to excellence? Look no further! Join Relucent Plastics Solutions, a leader in cutting-edge solutions in plastics, and be part of a team that embodies excitement, empathy, honesty, generosity, and a relentless focus on the positive.

Our Culture:

At RPS, we don't just work hard; we work smart. We believe in a healthy work-life balance, recognizing that a motivated and well-rested team is essential for success. Our positive and collaborative culture encourages personal and professional growth, ensuring that each team member feels valued and supported.

Quality and Customer Pleasure:

Quality is non-negotiable for us. We take pride in delivering top-notch products and services to our clients. Join a team that understands the importance of quality and is dedicated to exceeding customer expectations, ensuring satisfaction and success.

Who We Are Looking For:

We are seeking a Quality Manager who not only appreciates but shares our values. If you are passionate about innovation, thrive in a positive and inclusive work environment, and are committed to delivering excellence to our customers, we want to hear from you!

Summary:

The Quality Manager oversees and manages the organization’s Quality Management System (QMS). Manages the quality department and provides leadership direction to ensure the QMS is always on a path of continual improvements. Monitor that the processes are aligned with applicable ISO and FDA standards. Establishes best-in-class documentation that ensures ongoing compliance with regulatory and customer requirements. Promote a single source of truth data process to ensure date hygiene is established and maintained.

Researches and implements new or improved testing methodology, processes, tools, and operating systems. Works closely with customers, engineering, production, and vendors to develop and coordinate appropriate quality documented information. Responsible for ISO compliance system, and FDA requirements. Will provide consistent high-quality methodologies that are focused on continuous process improvement that is committed to exceeding applicable industry standards. Promotes a “Customer Focus” culture by providing solid leadership that will empower members of the organization to change and grow.

Essential Functions:

· Is the organizations Management Representative per ISO 134858-2016 clause 5.5.2.

· Designs, develops, and implements QMS process that supports its core processes.

· Manages the Quality department.

· Is the organization’s Lead Auditor and prepares and conducts internal audits. Monitors competency of auditors.

· Supports and oversees 2nd and 3rd party audit events.

· Manages client relations ensuring timely responses to technical questions and/or complaints.

· Provides essential QMS training related to process development, problem solving, root-cause analysis, and corrective action planning.

· Conducts data analysis to determine risks and opportunities within the business.

· Develops and manages Quality Manual and Teir 1 procedures to ensure compliance to industry and regulatory requirements. Communicates the importance of the Quality Policy.

· Leads cross-functional teams during process improvement events and provide training.

· Provides oversight to the management review activities.

· Assists in establishing best ERP system practices to establish proper inputs and outputs.

· Oversees quality type KPI’s that monitor the progress of core quality processes.

· Acts as the lead auditor of the QMS.

· Ensures proper processes are in place to manage control of nonconforming outputs.

· Assists with supplier management activities.

· Is the point of contact for registrar and regulatory agencies.

Competency:

· Proven experience in leading quality projects.

· Excellent knowledge of QMS associated with ISO 9001, 13485, and FDA Title 21 CFR Part 820.

· Process development and analytics.

· Capable of managing the internal audit program and capable to perform Lead Auditor duties.

· Able to support QC inspection activities and develop appropriate inspection plans to ensure product compliance.

· Good technical writing skills.

· Effective with team communications and sharing quality trends for awareness.

· KPI development and tracking.

· Effective trainer of the QMS and able to establish training programs.

· Able to resolve customer issues effectively to ensure ongoing mutual and beneficial relationships.

· Can perform supplier management activities to identify risks and opportunities.

· Supports engineering verification and validation activities per defined product drawings.

· Effective manager of department and able to resolve internal conflicts.

· Leads cross-functional teams during times of improvements using the appropriate TQM tools.

Supervisory Responsibilities:

· This position has direct supervision responsibilities.

· Responsible for PTO and timecard management for employees.

· Provides employee reviews to ensure competency is achieved/maintained.

Work Environment:

· General office environment.

· Moderate levels of stress may occur.

· Occasionally on the manufacturing floor and cleanroom areas.

· Quality Lab and equipment.

Physical Demands:

· Be able to properly bend and lift boxes up to 25lbs.

Position Type & Expected Hours of Work:

· Full time position Monday – Friday 40 hours a week.

· Able to support extra hours of work, if necessary, to keep on track with projects.

Travel:

· Less than 20% travel is expected.

Required Education / Experience:

· Bachelor’s degree in engineering and/or Associates in related field.

· 5 to 7 years’ experience in manufacturing, engineering, and/or quality.

· 3 years’ experience in 1st, 2nd, and 3rd party auditing.

· 3 year of leadership experience.

· Experience in managing conflict resolutions.

Additional Eligibility Qualifications:

· American Society for Quality (ASQ) Certification (QE, Auditing, Management Representative, calibration, inspections, etc.).

· Six Sigma yellow, green, and/or black belt training.

· Lean Manufacturing awareness.

· American Production and Inventory Control Society (APICS) awareness training.

· Formal leadership / management training.

Other Duties:

· This job description is an overview of the requirements for the listed job; duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.

Job Type: Full-time

Pay: $120,000.00 - $174,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Weekends as needed

Experience:

• QA/QC: 5 years (Preferred)

Ability to Relocate:

• Erie, CO 80516: Relocate before starting work (Required)

Willingness to travel:

• 25% (Required)

Work Location: In person