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.

• 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
• Read, understand, and follow work instructions and standard work
• Partner with other business segments:  sales/marketing, customer service, engineering, quality, and finance
• Understand customer needs and the core business markets we serve
• Ensure business systems are implemented, maintained, and functioning properly
• Participate in required company meetings
• Maintain an organized work area (5S)
• Participate in the Operational Excellence Program
• Complete all other work duties as assigned
• Ability to work in a manufacturing environment

• 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

All Employees:

Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 

20+hours:

Cretex’s medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 

30+ hours:

Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. 

(Some benefits are subject to eligibility criteria.)

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.