The role of the Supplier / Quality Auditor for DWK Life Sciences is a key role in the overall Quality system within DWK Life Sciences, and central to the administration of our ISO 9001:2015 & ISO 14001:2015 Certified Quality Management Systems. This role provides aspiring candidates with opportunity for expanded responsibilities, professional growth and corporate advancement within a leading global manufacturing business serving the life sciences research and packaging markets. We are looking for interested professionals that have ambition to become part of a global Quality & Compliance Department and to help sustain our track record of revenue growth. We are looking for candidates with a strong work ethic and a healthy curiosity to learn. Primary responsibilities include the effective application of our QMS to our manufacturing and sourcing operations, assisting with the supplier qualification audits and evaluation processes, assisting customers during on-site audits.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Ensure compliance with established procedures by examining records, reports, and documentation.
Using a 5 Why methodology effectively evaluate and provide a satisfactory root cause analysis for any non-conformance's identified during the audit process
Maintain and manage the internal activities for all DWK North America sites; to include audit planning, audit activities and close out
Assist with application of CAPA and continuous improvement processes
Work with cross functional departments to schedule on site vendor audits as part of the Supplier Qualification process
Prepare and distribute audit plans to necessary departments
Review audit responses to ensure corrective actions have been taken and are effective
Assist with supplier qualification and evaluation processes, including auditing, performance scoring and performance assessment
Represent DWK quality in customer site visits.
Maintain the contract database to ensure contracts, such as Non-Disclosure Agreements, Quality Agreements, Change Notifications, etc are current.
Responsible for direct oversight and hosting of customer audits at DWK Life Sciences and third party sites
Responsible for maintaining and providing, as appropriate, DWK Life Sciences self-audit questionnaires
Responsible to perform audits of third party suppliers of raw materials, component parts and finished goods
Maintain a database for issuance of customer change control notifications.
Provide technical quality auditing support to other sites as required.
Position Requires Domestic travel ~40%
Recognize his/her contribution to the effectiveness of the QMS including the benefits of improved performance.
Comprehend the impact or effect of not conforming with the QMS.
Observe all safety precautions, rules and regulations. Complies with and helps to enforce standard policies and procedures.
Maintains work area in a clean and safe manner.
Understanding of quality functions and manufacturing processes
Sound decision making ability
Ability to work independently
Good written and verbal communication
Capable reading and math skills
Ability to work in a team based environment with minimal day to day direction
Ability to follow written and verbal instructions/procedures
EDUCATION and/or EXPERIENCE:
Minimum Bachelors Degree or ASQ Lead Auditor Certification with a strong history of being trained and self-educated in a broad range of topics: quality systems, continuous improvement processes, organizational development, project management, ISO, etc.
Thorough understanding of the ISO 9001 & 14001 Standards.
3+ years as a Lead Auditor
Lead Auditor Certification
Strong prior experience in a customer driven environment is desired.
Proficient in MS Project, Excel, Word, and Powerpoint.
Internal Number: 02
About DWK Life Sciences
DWK Life Sciences (DURAN WHEATON KIMBLE) was created as a result of the merger of three industry leaders and provides the world’s laboratories and production environments with the most comprehensive range of labware for scientific research and technical applications as well as solutions for storage and packaging. We manufacture a full range of precision glassware and specialty products for life sciences. We also offer products and services (vials, ampules, stoppers, septa, seals, caps, bottles, tubes, flasks, and value added services) to customers seeking packaging solutions.
Company revenue is generated through four primary channels; (i) Global distributors, (ii) National Distributors, (iii) Direct Field selling efforts and (iv) Inside Sales selling efforts.
DWK Life Sciences supports four primary market segments; (i) Life Science Research, (ii) Life Science Production & Packaging, (iii) Industrial & Applied Science, and (iv) Clinical – Healthcare