Quality Manager

Overview

About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry.  Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly.  Learn more at www.cretexmedical.com.

Quality Manager Position Summary:

The Quality Manager will be responsible for building, managing, and leading the quality assurance department staff, working in partnership with sales, engineering, procurement, and operations, to ensure the highest possible quality products. This role will develop and implement effective, robust quality management system processes and methods in alignment with the FDA QSR and ISO requirements, and utilize metrics to continually improve quality processes and efficiency.

Responsibilities

Quality Manager Responsibilities:

• Develop, deploy, and execute Quality Policies, Quality Objectives, and Quality Plans that support the corporate strategic business goals and conform to customer, internal, ISO 9001:2015 and EN ISO 13485:2016, regulatory and legal requirements
• Support, develop, implement, and maintain all QMS processes and procedures, including but not limited to; Complaint Handling, Design and Development, Change Control, Risk Management, Corrective and Preventive Action, Internal Audits, Supplier Quality, Process Control, Document Control and Identification and Traceability
• Establish and lead a high-performing team of Quality Engineers, Quality Supervisor and Document Control, providing mentorship and coaching to staff as needed
• Ensure effective coordination of investigations, root cause analysis, risk assessments, field actions and implementation of change control and corrective and preventive actions to the adhered timelines
• Responsible for implementation, support, validation of computer system QMS modules
• Monitor and assess the QMS processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement, ensuring continued certification to applicable standards
• Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality system processes. Review and monitor trends, communicating issues to department management. Contribute to and assist in providing quality system training as appropriate
• Collect, analyze, and present data on the QMS during Management Review Meetings. Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause – corrective action
• Creating management level presentations and reports
• Ensure qualification, selection and monitoring of suppliers and any related quality issues
• Support a culture of Operational Excellence, inclusive of lean and six sigma principles
• Act as the Deputy Management Representative should need arise
• Act as a representative for external audits; customers, regulatory authorities, and registration agencies
• Support and comply with the company Quality System, ISO, and medical device requirements

Qualifications

Quality Manager Position Requirements:

• Bachelor’s degree in Engineering, Sciences, Quality, or relevant experience
• 8 years of experience in Quality Assurance or related management experience in manufacturing engineering or operations discipline, in a regulated field
• 5 years of leadership experience
• Experience with ISO 13485, ISO 14971 and GMP
• Auditing, writing procedures, supplier quality assurance, verification & validation
• In depth knowledge of FDA Quality System Regulation, Good Manufacturing Practices, 21 CFR Part 820 and cleanroom standards, or other relevant regulated requirements
• Excellent working knowledge of quality tools, variable and attribute sampling plans, root cause analysis, DOE, Statistics, Lean Manufacturing, and Six Sigma – an asset
• Demonstrated leadership skills with the ability to build and maintain an efficient, effective organization with a team focused on continual improvement
• Ability to prioritize, plan, and evaluate deliverables to established strategic goals and timelines
• Ability to consistently achieve short and long-term business results
• Ability to follow through on commitments and holds team members accountable
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills
• Attention to detail
• Organizational skills
• Ability to work in a fast-paced team environment
• Ability to prioritize and multitask

Quality Manager Preferred Knowledge, Skills and Abilities

• Continue Education, including participation in local chapters, associations, and/or organizations

What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.

Here are some of things that employees have said about working for Cretex Medical:

“The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.”

“I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.”

“I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.”

We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.

Company Benefits

Cretex Medical offers a full benefit package to its employees. Benefits include medical, dental, vision and life insurance options. Cretex Medical also offers a 401(k)-retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off and holiday pay.

Cretex Medical also offers company-specific benefits, such as:

• Employee Appreciation events
• Volunteer Opportunities
• Training and Development opportunities
• Tuition Reimbursement

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.