Quality systems manager job description

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

The Manager, Quality Systems & Compliance responsible for ensuring the Elkton manufacturing site quality system is running efficiently and effectively. The position will work with Corporate Quality and other key internal business/technical stakeholders to improve the TMC's electronic quality management system. This position will have responsibility for a team of associates as direct reports.

The Manager, Quality Systems & Compliance responsible for ensuring the Elkton manufacturing site quality system is running efficiently and effectively. The position will work with Corporate Quality and other key internal business/technical stakeholders to improve the TMC's electronic quality management system. This position will have responsibility for a team of associates as direct reports.
Job Details:

1. Manage and develop a team of Quality Systems professionals. Establish a high-performing team to drive the organizational goals & objectives and instill quality culture.
Develop, support, maintain, and continuously improve the TMC Elkton Quality system in accordance with applicable regulations for a global medical device corporation. Manage the efficiency, effectiveness, and compliance of the quality system to support the Elkton Manufacturing and Quality operations. Align the quality system to corporate quality system. Support corporate quality system improvement projects. Utilize process improvement and problem-solving methodologies to continuously improve the quality system.
3. Drive the operation of core quality system processes including CAPA, nonconformance, deviations, change management, and training with process ownership as laid out procedurally Ensure processes are compliant and records are high quality. Track & trend processes to monitor quality system performance. Establish and maintain governance boards to approve records and monitor system performance.
4. Conduct internal audits to assess compliance with applicable regulations and standards.
5. Lead third party/regulatory audits (Customer, Notified Body, FDA). Generate responses to observations in a clear and wholistic manner. Share recent audit observations from other entities for lessons learned.
6. Conduct management review with site leadership on a defined frequency. Ensure management is aware of current quality system performance, trends in products/processes, and changes that could impact our quality system.
7. Support the development of a proactive and preventive quality systems culture throughout the business.
8. Performs other job-related duties as assigned.
Knowledge, Skills, AbilitiesQuality and business process knowledge:Experience with FDA, ISO 13485, EU MDR, and multi-country Quality Systems requirements.Ability to navigate implementing products and processes in an efficient and compliant manner. Ability to use process development tools (ex. Lean Six Sigma) Ability to apply a practical level of statistics. Ability to develop and maintain spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports Leadership skills:Demonstrated ability to communicate and interact with all levels of the organization including management Strong interpersonal skills to provide coaching, training, and direction Ability to provide clear direction and mentor personnel. Individual skills required:Strong proofreading and writing skills, as well as exemplary attention to detail Strong organizational and prioritization skills Strong decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.Demonstrated initiative and ability to work independently while handling multiple tasks Strong computer knowledge (MS Office) Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.
Background, ExperienceB.S. degree or equivalent in Scientific or Engineering discipline required.Minimum 8 years' overall experience with at least 5 years of related experience in medical devices/diagnostics, pharmaceutical or other regulated industry required with a focus on quality system responsibilities. Previous managerial experience preferred.
It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

CTLGroup is an internationally recognized, award winning engineering, architecture, and materials science consulting firm. We provide expert insights and scientific solutions for our clientele. Join us, do interesting work, and GROW your career and expertise!
Essential Duties and Responsibilities:

* Create and maintain a written set of quality policies and procedures and that covers all critical processes within the firm (Quality Manual);
* Establish and maintain a Document Control System to ensure that procedures, work instructions, forms, and other relevant Quality Management System documents are maintained in a retrievable fashion and that controlled copies of these documents are available to appropriate personnel;
* Establish and implement an internal audit process to ensure that the Quality Management System is followed and is effective. Perform company-wide audits of quality processes and procedures with appropriate and corrective action where necessary;
* Facilitate continual improvement in the Quality Management System, in the work product, processes, and procedures of the firm;
* Establish and conduct Quality Management System training for existing and new employees;
* Monitor the status of measuring and test equipment, and alert personnel to upcoming out of calibration events (including verification, check, and standardization);
* Monitor the corrective action, notice of anomaly, nonconformance, client complaints, and deviation processes to ensure timely resolution of issues;
* Maintain, publish and update the Approved Suppliers List (ASL) for all key materials and services;
* Assist Groups with the implementation of the Quality Management System as it applies to specific needs within the Groups;
* Make recommendations to the President regarding quality issues and modifications to the quality program and systems;
* Create and implement firm's QMS processes and procedures;
* Establish and implement an internal audit process to ensure that the Quality Management System is followed and is effective. Perform company-wide audits of quality processes and procedures with appropriate and corrective action where necessary;
* Work closely with managers to ensure business needs are being met;
* Maintains high ethical standards by using sound judgment that benefits both CTLGroup and its customers.

Required Education and Experience:

* Bachelor's degree in Business, Engineer or related field;
* Minimum of eight years of relevant experience or equivalent combination of education and experience;
* Working knowledge of Quality Assurance Standards (i.e. ISO 9001, ISO 17025, NQA-1, AASHTO R18-10);
* Experience with implementing quality industry best practices;
* Experience in understanding business processes, systems, and performance metrics;
* Excellent presentation and communication skills;
* Ability to work independently with multiple levels of management and clients.

Preferred Education and Experience:

* Prior experience working with professional service firms.

Physical and Travel Demands:

* Work is performed in an office environment with exposure to prolonged sitting and use of computer;
* Up to 20% travel may be required.
* This job description describes the general nature of the position. The above declarations are not intended to be a complete list of responsibilities, skills and abilities required to do the job.

Make a +Difference at Kraton!

At Kraton, we make a Positive Difference, and we are looking for individuals who are also looking to make a difference in their jobs, for our customers and to the world.

Kraton is looking to add a key member to the Operations Support Team. The Global QA Manager will provide direction for quality, quality business process improvement activities and Continuous Improvement/Lean Six Sigma program for all Pine Chemical plants, offices and laboratories globally.

Key Responsibilities

* Develop and integrate the quality philosophy, policies, registration compliance and overall operating system(s) across Kraton.
* Ensure systems are developed and implemented that accurately captures and drives improvements in key quality measures (FTP, Cost of Poor Quality, Blocked Stock, Waiver Requirements, etc.).
* Work to drive Standardization of quality practices and systems across all Plants for things such as Process control / ppk Improvements, Quality complaints Investigation / Root Cause Analysis / Problem Solving, Visual Management such as Appearance Standards and other visual indications of quality, Quality Issue Escalation Process.
* Analyze the effectiveness of the plants Quality Management Systems and evaluate where continual improvements can be made.
* Act as our key manager for the Continuous Improvement/Lean Six Sigma Program, leading to an overall initiative to enhance the Lean Six Sigma methodology usage (LEAN, DMAIC, and DFSS/DMEDI) and substantially improve the quality performance of our operations.
* Strongly influences product commercialization success and leads major quality programs/projects development, while integrating Business & Operations strategies into actionable plans and results.
* Own the tolling management business process and portfolio of tollers. Ensure the correct cross functional resources are engaged in each tolling projects. Manage toller performance and compliance to agreements. Manage the toller governance process to ensure all projects have approved business support and are aligned with key stakeholders.

Required Skills

* 5-10 years of manufacturing experience.
* Quality Management systems experience within a similar industry.
* Continuous Improvement and Lean 6 Sigma Experience (Black Belt or Master Black Belt preferred).
* Excellent interaction and negotiation skills required as the job will interface w/ leadership levels from the top levels of the company through technical and operating staff.

Education, Certifications & Licenses

* Bachelor's Degree (Engineering or Chemistry), or other related 4-year technical degree.
* Certified Black Belt or Master Black Belt Preferred.
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The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Kraton's internal talent acquisition team manages our recruiting efforts and from time to time works with pre-selected/pre-approved external staffing agencies. We do NOT accept unsolicited resumes or candidate referrals from recruiters and/or agencies who are not pre-selected/pre-approved.

Kraton is proud to be an Equal Opportunity Employer.