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Cretex Medical · 2 days ago

Quality Manager

Bloomington, MN

Full-time

Onsite

Senior Level, Lead/Staff

$98K/yr - $147K/yr

8+ years exp

Cretex Medical is a company that offers critical end-of-line services for medical device OEMs. They are seeking a Quality Manager to lead the quality department, ensuring products meet quality management system requirements and drive quality improvements in alignment with FDA and ISO standards.

Health CareManufacturingMedicalMedical Device

No H1B

Responsibilities

Establish and lead a high-performing team of Quality Engineers, Quality Technicians, and Customer Facing Quality, providing mentorship and coaching to staff as needed

Manage customer quality communication and relationships. Assist in the resolution, documentation, customer responses for complaints

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

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

Professional and timely cross functional communication with other departments and customers

Monitor and assess the QMS processes for compliance, effectiveness, and opportunities for improvement, ensuring product meets requirements and continued certification to applicable standards

Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality of products. Review and monitor trends, communicating issues to department management. Contribute to and assist in providing quality system training as appropriate

Assures in process inspection, batch record review, sterile and product release complies with the quality system

Support the Management Review process. Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause – corrective action

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 customer audits, and support external audits by regulatory authorities and registration agencies

Qualification

ISO 13485FDA Quality System RegulationRoot cause analysisLeadership experienceLean ManufacturingSix SigmaQuality Management SystemTeam environmentCommunication skillsAttention to detailOrganizational skills

Required

Bachelor's degree in Engineering, Sciences, Quality, or relevant experience

8 years of experience in Quality or Engineering in a manufacturing setting in a regulated field

5 years of leadership experience

Clear and effective verbal and written communication skills

Strong attention to detail and organizational skills

In depth knowledge of 13485, 14971, FDA Quality System Regulation, 21CFR Part 820, Good Manufacturing Practices, or other relevant regulated requirements

Experience with Corrective and Preventative Actions, including the ability to lead cross functional teams to solve problems and complete root cause analysis

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, mentor and maintain an efficient, effective organization with a team focused on continual improvement and holds team members accountable

Experience with finished device manufacturing

Ability to prioritize, plan, and evaluate deliverables to established strategic goals and timeline

Ability to consistently achieve short and long-term business results

Ability to work in a fast-paced team environment

Preferred

Continuing education, including participation in local chapters, associations, and/or organizations

Benefits

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

Employee death benefit

Employee sick and safe leave

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

Discretionary profit sharing program

Parental Leave

Accident and critical illness benefits

Optional employee, spouse, and child life

Short and long term disability

Company provided life insurance

Tuition assistance programs