- Lead Quality Management System initiatives and continuous improvement activities.
- Generate project Quality Plans for the QMS and Organizational Objectives.
- Facilitate organizational compliance training and continual audit/assessment preparedness.
- Actively support site customer-requested auditing activities (Customer and Regulatory Agencies).
- Coordinate tracking/trending & reporting of quality system metrics and inputs to Management Review(s).
- Internal Auditing:
- Lead efforts to ensure all internal audits are performed as scheduled.
- Assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality Management System, including investigation observations/findings and reporting.
- Corrective/Preventive Actions (CAPA):
- Responsible for CAPA system administration, CAPA tracking and trending, and, as necessary, lead CAPA implementation efforts.
- Supplier Quality Management:
- Lead Qualification activities and maintenance of the Approved Supplier List (ASL).
- Monitor and facilitate timely execution of Supplier/vendor Corrective Actions (SCAR).
- Documentation Control:
- Support local Document Control (PLM) and Enterprise Resource Planning (ERP) systems.
- Complaints Investigation/Returned Materials Analysis:
- Knowledge of process(es) for investigation/analysis of returned/complaint materials.
- Nonconforming Material (NCM) Control:
- Knowledge of ID, traceability, containment requirements, Material Review Board (MRB) responsibilities and handling of NCM.
- Ensure compliance of all personnel to QMS requirements.
- Ensure adherence to training requirements regarding Quality Management System elements, controls, processes and procedures.
- Other duties and responsibilities as assigned.
- Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
- Minimum of 4-6 years' experience in a regulated manufacturing environment.
- Advanced Post-Secondary Education/Training/Certification coursework
- Quality certification(s) (e.g. ASQ CQE, QCI, etc.).
- Class I, II and/or III Medical Device manufacturing experience.
- Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
- Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
- Experience in effectively supporting audits by customers and external regulatory agencies.
- Strong verbal and written English language communication skills.
- Successfully meet TOMZ-specific positional/functional on-the-job training requirements.
- Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
- "Hands-on" self-starter with ability to work both independently and as part of a team.
- Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.
-
Quality Systems Specialist
3 weeks ago
TOMZ Corporation Knightstown, United StatesTOMZ Corporation is looking for a Quality Systems Specialist to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision an ...
-
Quality Systems Specialist
3 weeks ago
Tomz Knightstown, United StatesTOMZ Corporation is looking for a Quality Systems Specialist to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision an ...
-
Quality Systems Specialist
2 weeks ago
Tomz Knightstown, United StatesTOMZ Corporation is looking for a Quality Systems Specialist to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision an ...
-
Training for Specialist in System Gastronomy
4 days ago
Nexus Dynamics Beech Grove, United StatesTraining Specialist for System Gastronomy (m/f/d) at Beech Grove · Start your career with our training program. Learn from one of the largest restaurant brands and the best, diverse teams. - Top training at the number 1 in system gastronomy. - Good training salary according to co ...
-
Chemical Technician Full-time from
4 days ago
Oceanic Ventures Knightstown, IN, United States Freelance**We are currently seeking a trained Chemist for our client in the chemical industry in Knightstown, IN:** · Our client is a globally operating corporation in the fields of specialty chemicals and high-performance materials with over 33,000 employees worldwide. As a framework con ...
-
Trainer / Training Coordinator (m/f/d)
4 days ago
Nexus Innovations Carthage, IN, United States FreelanceCompany Description: · Revalize is a global leader in providing industry-specific software solutions that help manufacturers optimize their revenue through design applications, technical simulations, product selection, CPQ, PLM, visualizations, and data analytics. · Based in Jack ...
-
Machining mechanic
4 days ago
Titan Industries Spiceland, United StatesYour perfect start into your professional life · In the first months of your apprenticeship, you will learn the basics of manual machining in turning and milling. Building on this, you will be taught how to operate modern production machines and how to program CNC machines. After ...
-
25U Signal Support Systems Specialist
1 week ago
Army National Guard Shelbyville, United StatesJob Description · Communication is the pulse of Army National Guard units, and it's up to the Signal Support Systems Specialist to ensure the information keeps flowing so the military doesn't miss a beat. · Signal Support Systems Specialists are responsible for integrating sign ...
-
ZephyrTech Lewisville, IN, United States FreelanceThe company · As a leading premium provider for heating technology, the company is the market leader with an excellent reputation. The group has a significant advantage in renewable products. In Germany, our client stands out for its cooperative leadership style and is a modern, ...
-
Stellar Innovations Gwynneville, United StatesIntroduction: · To strengthen our existing team, SPIE SAG GmbH, a specialist in energy infrastructure in the CityNetworks & Grids business unit, is looking for several · Tasks: · Carrying out assembly work in the areas of 1kV low-voltage network up to 10 kV medium-voltage network ...
-
Ventilation Site Manager
4 days ago
Omega Dynamics Straughn, United StatesGA-tec Building and Plant Technology GmbH, a subsidiary of the Sodexo Group, is one of the most powerful technical building equipment suppliers and providers of technical facility management. With more than 1200 employees from numerous branches throughout Germany, we continuously ...
-
Youth Development Specialist
1 week ago
State of Indiana Knightstown, United StatesYouth Development Specialist · Date Posted: May 7, 2024 · Requisition ID: 441942 · Location: · Knightstown, IN, US, 46148 · Work for Indiana · Grow your career with the State of Indiana With more than 50 executive branch agencies, the State of Indiana is a diverse workforce offer ...
-
IT - System Administrator (m/f/d)
3 weeks ago
Radiant Ventures Greens Fork, United StatesIT - System Administrator (m/f/d) alltours Headquarters Düsseldorf Full-time The alltours Group with its several thousand employees is one of the largest European tour operators and stands for the principle of high-quality travel at affordable prices - simple and fast. We believe ...
-
Junior IT Administrator for Customer Systems
4 days ago
Phoenix Ventures Manilla, United StatesWhat can you expect? · You will analyze and resolve operational disruptions in Level-2 IT support for customer systems in collaboration with colleagues and customers · You will develop and implement operational concepts and consultations with our software development, product and ...
-
ZephyrTech Beech Grove, United StatesAt the earliest possible date, we are looking for a specialist (m/f/d) in radiology for a client in Lower Saxony. The employer employs highly professional staff, for whom a wide range of training and further education opportunities are available. The radiology practice offers the ...
-
Training for
3 weeks ago
NovaTech Solutions Boggstown, United StatesDuring your 3-year apprenticeship in our IT department in Boggstown, you will learn to combine theory and practice directly. This provides you with a perfect start for your everyday work and your future. You will learn to plan, configure, and implement IT systems, as well as offe ...
-
Resident Physician
3 weeks ago
FusionTech Wilbur Park, United StatesAt the earliest possible date, we are looking for an Assistant Doctor (m/f/d) for Vascular Surgery for a client in Lower Saxony. The primary care provider, with approximately 300 beds and 10 specialist departments, employs over 1000 staff members. As an academic teaching hospital ...
-
NovaWorks Connersville, United States InternshipSHIPLocation: 50668 Cologne | Contract type: Full/Part-time, temporary | Job ID: 792024 · What you will be doing: · We need your support: You will primarily take on administrative tasks in the HR-Payroll Services team. · You will take responsibility: You will be responsible for creat ...
-
Technical E-commerce Specialist
4 days ago
ZephyrTech Brownsville, IN, United States FreelanceWe are currently seeking a Technical E-Commerce Specialist (m/f/d) to join our team in Brownsville, IN. In this role, you will be responsible for the technical implementation and optimization of our E-commerce platform, ensuring that our online sales channels run smoothly and pro ...
-
Phoenix Innovations Connersville, United StatesDo you enjoy being on your feet, want to reach new heights in our high-bay warehouse, and are fascinated by forklifts? · Then an apprenticeship as a specialist for warehouse logistics at Brand Group in Connersville is the perfect fit for you. Here, you will become an expert in m ...
Quality System Specialist - Knightstown, United States - Tomz Corporation
Description
Job Description
Job DescriptionQuality Systems Specialist
Knightstown, IN
Reports to: Quality Systems Manager
TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Systems Specialist to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains modern, clean, and safe facilities with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO
SUMMARY OF POSITION:
The position will be responsible for ensuring global operational adherence and compliance to TOMZ's Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.
ESSENTIAL FUNCTIONS:
QUALIFICATIONS:
Education
Experience
Preferred Skills/Qualifications
Physical Demands
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.
This position will minimally require intermittent travel between TOMZ Corporation sites and/or supplier facilities within the United States.