- Manage all audit related activities for client's Audit program which includes supplier, corporate facility, and third-party audits.
- Perform corporate facility audits of client's sites to ensure compliance with procedures and applicable standards and regulatory requirements.
- Perform audits of client's suppliers to assess their Quality Management System, and ability to meet client's quality standards, and applicable regulations. Provide Audit support for supplier selection process for new product development and procurement second sourcing strategies.
- Develop and manage global strategies for standardized audit processes, audit tools, and audit plans and ensure use in all audit activities.
- Manages and supports post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts.
- Manage global audit schedule(s); Partner with key stakeholders to develop risk-based audit planning. Evaluate executed audits, including customer audits, to define current quality trends identified as risks/issues and determine impact on global quality systems and initiate actions, as needed.
- Manage global relationship and activities of client's third-party audit providers; Establish expectations and ensure Third Party audit providers perform as expected.
- Establish and manage Auditor matrix which identifies trained auditors and areas of expertise; Enhance auditor training program to include specific trainings to expand auditor expertise and increase auditing capabilities. Establish processes and tools to increase visibility of audit and audit findings in a standardized format to client leadership.
- Support the ongoing update of the QMS in line with emerging issues or changes to regulatory expectations.
- Collaborate with Supplier Quality Management to ensure alignment with supplier risk mitigation strategy and communicate on audit program priorities.
- Generate, review, or approve Quality Assurance related documentation required for product.
- Other duties as assigned.
- Bachelor's Degree in Engineering or related technical discipline required
- Master's Degree preferred
- Minimum 8 years (Mgr.) related experience required
- Preferred Knowledge, Skills, and Abilities:
- Experience in regulated industry such as pharmaceutical and medical device.
- In depth knowledge of cGMP, cGDP, relevant ISO standards and medical device requirements.
- Experience with SAP systems
- Familiarity with document management databases, particularly MasterControl
- Use written and oral communication skills. Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making
- Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of customer visits and business development related activities.
- Must maintain the ability to work well with others in a variety of situations
- Must be able to multi-task, work under time constraints, problem solve, and prioritize
- Ability to make independent and sound judgments
- Observe and interpret situations, analyze, and solve problems
- Certified Software Quality Engineer (ASQ CSQE) preferred
- Six Sigma Green Belt Certification preferred
-
Quality Systems
3 weeks ago
ACE Partners Kinston, United StatesQuality Systems & Compliance Manager · North Carolina - Kinston · Salary: $130k + 15% bonus · PTO: 20 days · Job Summary: · Lead global strategies for Supplier, Corporate Facility, and Third-Party audits, ensuring quality standards across business units. · Analyze Customer audit ...
-
Quality Systems
2 weeks ago
IntePros Kinston, United Stateshe Quality Systems and Compliance Manager will lead global strategies and continuous improvement initiatives for Supplier, Corporate Facility and Third-Party audits, across our multiple business units to ensure all meet intended level of quality for products and services. In addi ...
-
Quality Systems
3 weeks ago
IntePros Kinston, United Stateshe Quality Systems and Compliance Manager will lead global strategies and continuous improvement initiatives for Supplier, Corporate Facility and Third-Party audits, across our multiple business units to ensure all meet intended level of quality for products and services. In addi ...
-
Quality Systems
2 weeks ago
ACE Partners Kinston, United StatesQuality Systems & Compliance Manager · North Carolina - Kinston · Salary: $130k + 15% bonus · PTO: 20 days · Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding. · Job Summary: · Lead global strategi ...
-
Quality Systems and Compliance Manager
3 weeks ago
West Pharmaceutical Services Kinston, United StatesAt West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government durin ...
-
Quality Systems and Compliance Manager
3 weeks ago
IntePros Consulting Kinston, United StatesIntePros is currently looking for a Quality Systems and Compliance Manager to join one of our growing medical device clients in Kinston, NC. The Quality Systems and Compliance Manager will lead global strategies and continuous improvement initiatives for Supplier, Corporate Facil ...
-
Production Associate
2 weeks ago
Three Stacks Distilling Co. Kinston, United States**About us** · Three Stacks Distilling Co., LLC is a distillery located in Kinston, North Carolina. A high-capacity production craft distillery, the company produces and markets its brands, such as Social House Vodka, and offers contract distilling services, brokerage, barrel war ...
-
Spectrum Dynamics Lenoir, United States"We are looking for motivated employees for over 500 different professions. And that's all over Germany. Whether experienced professionals or career starters - we offer numerous entry and further training opportunities. · We are currently looking for you as a construction techni ...
-
FusionTech Lenoir, United StatesETC is an international high-tech company whose main business is the development, manufacturing, and installation of gas centrifuges for uranium enrichment. ETC also supplies its customers with aluminum piping and provides project management, plant design, and engineering service ...
-
Shipping Employee
3 days ago
Diamond Dynamics Lenoir, NC, United States Freelance**Shipping Worker (gn) in Lenoir, NC** · Are you a meticulous worker who never wastes time? Then you've come to the right place Our client TJX in Bergheim is looking for you Start as a shipping worker (gn) in the fashion department · Manpower is a pioneer in the field of personne ...
-
beBee Handyman Kinston, NC, United States FreelanceI am in need of a pool construction service in Kinston, NC with the following characteristics:Type of work to be done · Construction · Pool material · Shotcrete (gunite) · Pool size · Over 35 m2 · Pool depth · Between 1.60 and 2.10 meters · Pool shape · Rectangular · Intended use ...
-
Foster Care Case Manager
4 days ago
Baptist Children's Homes of NC, Inc. Kinston, United States**Turn your calling into a career at Baptist Children's Homes of NC** · **OUR MISSION: Sharing hope... changing lives.** · **OUR VISION: To provide the highest quality of Christian services to children, adults, and families in a caring culture of measurable excellence.** · **FOUN ...
-
Employee/ Personnel Manager/ Career Changer
3 days ago
Apex Ventures Graingers, NC, United States FreelanceTo strengthen our team, we are currently seeking a Personal Coordinator in Magdeburg for a permanent position. · We are a competent personnel service provider in the event industry and have been supporting numerous clients and partners worldwide with our employees since 2001. · O ...
-
Sr Director Digital System Quality Assurance
6 hours ago
Thermo Fisher Scientific Greenville, United StatesWork Schedule · Other · Environmental Conditions · Office · Job Description · Job Description: Senior Director, Quality · Job Title: Senior Director of Digital System Quality Assurance, Global Quality Systems, Pharma Services Group · When you're part of the team at Thermo ...
-
Sr Director Digital System Quality Assurance
5 days ago
Thermo Fisher Scientific Greenville, United StatesWork Schedule · Other · Environmental Conditions · Office · Job Description · Job Description: Senior Director, Quality · Job Title: Senior Director of Digital System Quality Assurance, Global Quality Systems, Pharma Services Group · When you're part of the team at Thermo Fisher ...
-
beBee Handyman Deep Run, NC, United States FreelanceI am in need of a service to install solar panels with the following characteristics in Deep Run, NC:What type of service do you need? · Installation · How many panels need to be installed or repaired? · What is the average cost of your electricity bill? · Between 100 € and 200 € ...
-
Dunkin' Team Member
2 weeks ago
Dunkin' | Ricky Patel Goldsboro, United States**Full Job Description**: · Required · 16 years or older · Legally authorized to work in the United States · **Available shifts**: · Night shift, Day shift, Weekend availability, 8 hour shift, Holidays, Sunday to Saturday · **Shift**: · - 10 hour shift · - 12 hour shift · - 8 hou ...
-
Travel Nurse RN
1 week ago
TWG Staffing Kinston, NC, United StatesTWG Staffing is seeking a travel nurse RN ICU - Intensive Care Unit for a travel nursing job in Kinston, North Carolina. · Job Description & Requirements · Specialty: ICU - Intensive Care Unit · Discipline: RN · Start Date: 06/10/2024 · Duration: 13 weeks · 36 hours per week · Sh ...
-
Shift Leader
2 weeks ago
Papa John's Kinston, United StatesPay is $10-16/hour based on location, volume of sales & experience. · BENEFITS: · * Food Discounts · * Paid Time Off · * Flexible Hours · * Training Program · * 401K Program · * Opportunity for Advancement - YOU have the potential to one day become a Franchisee · * Along with a c ...
-
Travel Nurse RN
1 week ago
Travel Nurses, Inc. Kinston, United StatesJob Description · Travel Nurses, Inc. is seeking a travel nurse RN PACU - Post Anesthesia Care for a travel nursing job in Kinston, North Carolina. · Job Description & RequirementsSpecialty: PACU - Post Anesthesia Care · Discipline: RN · Duration: 12 weeks · 40 hours per week · S ...
Quality Systems - Kinston, United States - IntePros
Description
he Quality Systems and Compliance Manager will lead global strategies and continuous improvement initiatives for Supplier, Corporate Facility and Third-Party audits, across our multiple business units to ensure all meet intended level of quality for products and services. In addition, this role will trend client Customer audits to identify continuous improvement needs for client's system and processes.
Quality Systems and Compliance Manager Responsibilities:
Quality Systems and Compliance Manager Basic Qualifications:
Quality Systems and Compliance Manager Work Experience:
Licenses and Certifications:
