- Lead the Quality staff to ensure compliance with the Quality Management System and drive continuous improvement.
- Collaborate with senior management to provide strategic direction and develop quality strategies.
- Mentor the Quality staff and serve as the site's Management Representative.
- Ensure compliance with regulatory standards and drive the continuous improvement process.
- Managing CAPA, complaint, and non-conformance processes to drive process improvements.
- Overseeing Regulatory Agency and Notified Body inspections and implementing remediation plans.
- Participating in Customer audits and ensuring regulatory compliance.
- Traveling to support activities in other AST facilities, domestically and/or globally.
- Bachelor's Degree in a related scientific/technical field.
- Minimum 5 years of people leadership experience, with 2 years in a Quality leadership role.
- Experience in an ISO certified environment and combined Manufacturing/Quality Engineering.
- Experience in medical device or other regulated industries.
- Knowledge of FDA QSR/EUGMP regulations.
- Excellent problem-solving skills and ability to work in a fast-paced environment.
- Effective interpersonal, organizational, and communication skills.
- Proficiency in MS Office applications like Excel, Word, and PowerPoint.
-
Sr Quality Systems Engineer
1 week ago
Proterra Inc Greer, United StatesAbout the Role - You will:As a Sr. Quality Systems Engineer is responsible for defining, maintaining, and improving quality systems and its tiered documentation. This role is responsible for leading the ISO/ IATF certification, VDA implementation and continued compliance to the r ...
-
Business Systems and Quality Analyst
4 days ago
Kopis Greenville, United StatesAre you the best at what you do? We're the place the best want to work · Are you a Business Systems and Quality Analyst with a passion for helping customers succeed? Are you highly skilled in becoming a subject matter expert in business processes and software applications? Do yo ...
-
Sr. Quality Systems Engineer
3 weeks ago
Volvo Battery Solutions, LLC Greer, United States FreelanceSr. Quality Systems Engineer - Contractor · Job Category · : · Quality · Requisition Number · : · QUALI003804 · Apply now · Posted : May 1, 2024 · Part-Time · On-site · Locations · Showing 1 location · Greer, SC 29651, USA · Description · About the Role – You will: · As a ...
-
Senior Quality Assurance Specialist
5 days ago
Keurig Dr Pepper San Francisco, United States PermanentThe Spartanburg operation is a state-of-the-art coffee roasting and pod packaging facility in addition to hosting a full beverage distribution center. Spartanburg is the largest KDRP manufacturing and distribution location. The site will operate on the foundational principles of ...
-
QMT Analyst
1 week ago
BMW Manufacturing Co., LLC Spartanburg, United States Full timeDescription · The QMT Analyst: · Coordinates and supports supplier quality systems for Plant Spartanburg's purchased parts (world-wide). · Participates in the development of new supplier's quality and production systems to ensure that BMW MC's purchased parts meet product specifi ...
-
Maintenance Technician
1 day ago
Keurig Dr Pepper Spartanburg, United States Full timeShift: N1 - Sun., Mon., Tues.; Alternating Sat. 6:30 pm - 7:00 am · The Spartanburg operation is a state-of-the-art coffee roasting and pod packaging facility in addition to hosting a full beverage distribution center. Spartanburg is the largest KDRP manufacturing and distributio ...
-
Regional Quality Manager
1 week ago
Magna Spartanburg, United States Permanent/RegularJob Number: 44642 · Group: Cosma International · Division: Cosma USA Group Office · Job Type: Permanent/Regular · Location: MCCALLA, Greenville, SPARTANBURG, BIRMINGHAM, DUNCAN, GREER, MOORE, PIEDMONT · Group Description · Cosma provides a comprehensive range of body, chassi ...
-
Quality Technician II
6 days ago
Oshkosh Spartanburg, United States Full timeAbout Oshkosh Defense, an Oshkosh company · Oshkosh Defense stands behind those who dedicate their lives to protecting others. As an industry-leading tactical vehicle manufacturer, every day we strive to meet or exceed our customers' ever-changing needs with next generation defe ...
-
Manufacturing Engineer
2 days ago
Polydeck Spartanburg, United StatesJob Purpose/Summary: · The Manufacturing Engineer is a crucial manufacturing support resource. This individual will be involved in the start up of a robotic induction welder and responsible for the industrialization of two product lines within that new department. Additionally th ...
-
IT Advanced Quality Assurance Analyst I
4 weeks ago
Milliken and Company Spartanburg, United StatesCOMPANY OVERVIEW · Milliken & Company is a global manufacturing leader whose focus on materials science delivers tomorrow's breakthroughs today. From industry-leading molecules to sustainable innovations, Milliken creates products that enhance people's lives and deliver solutions ...
-
Process Control Engineer
2 days ago
Auriga Polymers Inc. (Indorama Ventures) Spartanburg, United StatesIndorama Ventures is a world-class sustainable chemical company with a globally integrated PET polymers and fibers, serving major customers in diversified end-use markets. Following our core strategies, we develop innovative products for customer needs, making great products for ...
-
Administrator I, Client Systems
13 hours ago
Toray Composite Materials America, Inc. Spartanburg, United States Full timeJob Details · Description · Provide Help Desk support to resolve all reported issues with IT systems and services. Perform escalations to Tier 2 IT staff when needed. Utilize administrative software tools to provide advanced user support within systems across multiple sites. Id ...
-
Bunnell-Lammons Engineering, Inc Spartanburg, United StatesBunnell-Lammons Engineering, Inc. (BLE) has an opening for a Property Condition Assessor and Building Inspector at our Greenville, South Carolina office. This individual will be assisting our Project Managers with completing and finalizing Property Condition Assessments based on ...
-
CNC Set Up Tech Operator
13 hours ago
OpSource Staffing Spartanburg, United States Temp to HireThe CNC Set-up Tech Operator is responsible for running a production machine following established procedures and guidelines. The operator will adjust machine settings to complete tasks accurately, based on specifications, and under the guidance of a supervisor, ensuring timely c ...
-
Global Operations Director
2 weeks ago
Anderson-Negele Spartanburg, United StatesIn this role, the Global Operations Director will set the strategy and optimize operations across two dozen manufacturing cells in Spartanburg, South Carolina; Fultonville, New York; and Egg, Germany. They'll lead production, supply chain, quality, and manufacturing engineering t ...
-
PRN Occupational Therapist
4 weeks ago
Spartanburg Regional Healthcare System Spartanburg, United StatesSummary · Spartanburg Medical Center Mary Black Campus (SMC-MB) is a division of Spartanburg Regional Healthcare System. Our rehabilitation team consists of PTs, PTAs, OTs, COTAs, and SLPs who work collaboratively to provide excellent patient care in our 230-bed acute care hospi ...
-
PRN - Rehab Tech
1 week ago
Spartanburg Regional Healthcare System Spartanburg, United StatesSummary · Spartanburg Medical Center Mary Black Campus (SMC-MB) is a division of Spartanburg Regional Healthcare System. Our rehabilitation team consists of PTs, PTAs, OTs, COTAs, and SLPs who work collaboratively to provide excellent patient care in our 230-bed acute care hospi ...
-
Baker
2 weeks ago
Golden Corral Spartanburg, United States Full timeOur franchise organization, Jax, LLC dba Golden Corral, is currently seeking energetic, friendly individuals to join our team The Baker has the important responsibility of preparing yeast rolls, cakes, pies, specialty desserts and other freshly baked products. The Baker always pa ...
-
Industrial mechanic
3 weeks ago
BlueNova Industries Camp Croft, United StatesAre you interested? · If so, please send your complete application · via email to: · or · via mail to: Marston-Domsel GmbH, Attn: Mr. Martin Esser, Bergheimer Str. 15, 53909 Zülpich · Marston-Domsel GmbH is a medium-sized company in the chemical industry. We are a manufacture ...
-
Patient Access Representative
2 weeks ago
Spartanburg Regional Healthcare System Spartanburg, United States Full timeSummary · Position Summary · The Patient Access Representative position receives, coordinates, and implements the initial patient experience by providing critical functions essential to ensuring proper clinical treatment, billing and reimbursement, patient satisfaction as well a ...
Manager, Quality Systems - Spartanburg, United States - STERIS
Description
At STERIS, we contribute to creating a healthier and safer world by offering innovative healthcare and life science solutions worldwide.
Quality Manager Role at STERIS
The Quality Manager in our facility in Spartanburg, South Carolina, plays a crucial role in leading quality improvement efforts for an Applied Sterilization Technologies (AST) processing or lab facility. This position involves implementing and maintaining cutting-edge quality practices to ensure the site complies with domestic and international standards such as ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137, and/or ISO 11135. The Quality Manager oversees the quality system's organization, documentation, and compliance, focusing on quality system enhancement, supplier quality, process quality, and regulatory standards adherence.
Key Responsibilities:
STERIS offers a rewarding environment where your hard work is valued. We provide competitive salaries, healthcare benefits, tuition assistance, paid time off, and more. Join us in shaping the future at STERIS!
STERIS is a global leader in infection prevention, supporting patient care with innovative products and services. With over 17,000 associates in 100+ countries, we are dedicated to making a positive impact on healthcare worldwide.
STERIS is an Equal Opportunity Employer, committed to diversity and equal employment opportunities for all individuals without discrimination.
