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Supplier Quality Engineer/ Sr. Supplier Quality Engineer

2 months ago

Racine, Wisconsin, United States Merz North America Full time

About the Company: Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.

Responsible for the daily oversight of vendors, in accordance with product risk profile. Primary Quality Contact for Merz to critical vendors. Merz is as responsible for its products that are manufactured by vendors as the product manufactured in Merz facilities. Oversight and accountability include but is not limited to supplier audits, supplier re-evaluations, supplier score carding, supplier corrective action management, and the facilitation and implementation of process improvement projects.

Fulfill the role of product and process SME and / or facilitate the communication between vendor and applicable SME. Evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are necessary. Coordinate and execute finished product / raw material management as appropriate to the Quality Department. Provide direct support to Quality Management/Quality Assurance personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed.

Key Responsibilities:

Sr. Supplier Quality Engineer

Supplier Quality

  • Oversee and manage day to day interface with suppliers that manufacture for and supply products to Merz North America predominantly Medical Device (510K, PMA), but also including Biologics, Rx, OTC, Cosmetics and Nutritional Supplements.
  • Ensure products are consistently manufactured in accordance with Tech Files, Dossiers, Specifications etc.

Nonconformances/ SCARs

  • Drive the operation of the Quality System process related to Corrective/Preventive actions and product non-conformance control including capturing data associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.

Audit

  • Coordinate/Execute the operation of Internal and Supplier Audit Systems. Provide leadership as required while conducting all such audits.

Process Improvement

  • Provide leadership in directing and promoting Quality Improvement processes.

Inspections

  • Assist with continued company certification to the appropriate Quality System Standards and Regulations and assist with all related inspections as required.

Compliance

  • Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical device, drugs, cosmetics, and dietary supplements.

Managerial

  • Manage staff, resources, and procedures to support Merz Supplier Quality function. Coach and mentor employees to optimum performance, and recruit and interview qualified applicants, ensure appropriate new.

Other duties as assigned.

  • Provide support within the Quality department and to other Merz Aesthetics departments as directed by Quality Management.

Supplier Quality Engineer

Supplier Quality

  • Oversee and manage day to day interface with suppliers that manufacture for and supply products to Merz North America (including Biologics, Rx, OTC, Medical Devices (510K, PMA), Cosmetics and Nutritional Supplements).

Nonconformances/ SCARs

  • Drive the operation of the Quality System process related to Corrective/Preventive actions and product non-conformance control including capturing data associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.

Audit

  • Coordinate/Execute the operation of Internal and Supplier Audit Systems. Provide leadership as required while conducting all such audits.

Process Improvement

  • Provide leadership in directing and promoting Quality Improvement processes.

Managerial

  • Manage staff, resources, and procedures to support Merz Supplier Quality function. Coach and mentor employees to optimum performance, and recruit and interview qualified applicants, ensure appropriate new.

Inspections

  • Assist with continued company certification to the appropriate Quality System Standards and Regulations and assist with all related inspections as required.

Compliance

  • Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical device, drugs, cosmetics, and dietary supplements.

Further Tasks

  • Provide support within the Quality department and to other Merz Aesthetics departments as directed by Quality Management.

Education:

  • BS in a Physical Science or Engineering, or equivalent experience.

Professional experience:

Sr. Supplier Quality Engineer

  • Minimum 6 years combination of Medical Device and/or pharmaceutical experience.
  • ASQ Certification as a Quality Engineer, Lead Auditor or equivalent.

Supplier Quality Engineer

  • Minimum 2-4 years Quality Assurance and/or other regulated industry or similar experience.
  • ASQ Certification as a Quality Engineer, or equivalent

Knowledge, skills, and abilities:

Sr. Supplier Quality Engineer/Supplier Quality Engineer

  • Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines.
  • Strong technical and general problem-solving skills.
  • Ability to work with company staff and communicate effectively throughout the organization.
  • Ability to host, facilitate and execute audits with internal and external audiences.
  • Excellent written and oral communication skills with attention to detail.
  • Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
  • Experience with statistical analysis of data.
  • Ability to work effectively in a global, matrix environment.
  • Ability to work independently as well as direct and control the efforts of Direct Reports, as applicable.
  • Strong interpersonal skills and ability to collaborate effectively with various technical area experts.

Sr. Supplier Quality Engineer

  • Medical Device Design Control

Benefits:

  • Comprehensive Medical, Dental, and Vision plan.
  • 20 days of Paid Time Off
  • 15 paid holidays
  • Paid Sick Leave
  • Paid Parental Leave
  • 401(k)
  • Employee bonuses
  • And more

Your benefits and PTO start the date you're hired with no waiting period
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees