Quality Assurance Manager - Healthcare jobs in Erie, PA

Job Overview:
CSI Industries, Inc. conducts business within the concept of TEAMWORK; whereby all employees including members of management, sales, accounting, engineering, purchasing, quality, manufacturing & production, shipping, and maintenance, are all working together as a TEAM, toward the same goal: to help continue the growth of CSI Industries Inc, for the benefit of all employees. At CSI, we are committed to continuous improvement to our Quality, Delivery and Service to our Customers.

Position Summary

The Quality Manager is responsible for leading the quality improvement for a metal fabrication facility. This position leads by implementing and maintaining state-of-the-art quality practices and assumes overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards.

The role is responsible for the organization, documentation and maintenance of the quality system to be compliant with, ISO 9001, This role leads the site efforts focused quality system improvement, supplier quality, process quality, and quality system compliance. The Quality Manager serves as the Management Representative for the site and is responsible for ensuring the quality system meets all applicable regulatory standards.

The Quality Manager has the responsibility, duty and decision-making authority to put any product on hold that is identified as potentially non-conforming and escalating as needed for additional reviews by engineering.

What You Will Do

• Lead the organization to ensure compliance to the overall Quality Management System and drive continuous improvement.
• Serve as the site’s Management Representative and lead the organization’s Management Review process.
• Lead the organization's continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics.
• Manage the CAPA, complaint and non-conformance handling processes to ensure customer responsiveness and process improvements.
• Responsible for developing and executing inspections and inspection frequency.
• Drive timely and effective root cause analysis and provide quality leadership to suppliers.
• Serve as quality engineering support to new product development design, testing, and introduction ensuring the attainment of key quality deliverables and quality targets.
• Manage the creation of new quality system policies, procedures, and revisions to existing policies/procedures.
• Monitor and report on performance metrics.
• Perform other duties as assigned.

What You Will Need to Be Successful

• 5 years of Quality Management, Quality Engineering and/or Quality Systems experience.
• A minimum of (5) years of experience working in a manufacturing environment.
• Excellent problem-solving skills including FMEA or root cause analysis and implementation of Corrective and Preventive Actions.
• Leadership ability to coordinate projects in a cross-functional team environment.
• Effective organizational, oral and written communications skills
• Computer skills and experience with applications such as EXCEL, Minitab, Word.
• Excellent organizational skills and time management skills.
• Ability to effectively read, write and verbally communicate in English.
• Capable of completing statistical and data analysis using statistical tools such as MS Excel for KPI reporting and trending.
• Ability to work independently under general guidelines and supervision.
• Strong influencing and interpersonal and communication skills to build effective working relationships across all key functions.
• Effective analytical and problem-solving skills.
• A proven track record of working in a fast-paced environment with strong technical capabilities and be capable of handling multiple development aspects of assigned projects.
• Ability to adapt to changing duties and responsibilities.
• Ability to influence people in their opinions, attitude, or judgements; to generalize, evaluate and make decisions in stressful situations.

What May Help You

• Bachelor’s Degree in a related scientific/technical field.
• 10 years of experience working in an ISO certified environment
• Lean Operations experience.
• Direct experience in a IATF 16949 Quality Management System

What CSI Industries Offers

The opportunity to join a company that will invest in you for the long term. CSI Industries couldn’t be where it is today without our people. That’s why we share in our success together by rewarding you for your hard work. We do this by providing competitive salaries, healthcare benefits, paid time off, holidays, matching 401(k), and merit plans.

Job Type: Full-time

Pay: $40,000.00 - $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Ability to Relocate:

• Fairview, PA 16415: Relocate before starting work (Required)

Work Location: In person