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).
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.
Coordinate/Execute the operation of Internal and Supplier Audit Systems. Provide leadership as required while conducting all such audits.
Provide leadership in directing and promoting Quality Improvement processes.
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-hire training and orientation, and provide on-going training and development of Quality Team.
Assist with continued company certification to the appropriate Quality System Standards and Regulations, and assist with all related inspections as required
Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical device, drugs, cosmetics and dietary supplements.
Provide support within the Quality department and to other Merz Aesthetics departments as directed by Quality Management.
BS in Physical Science or Engineering, or equivalent experience required.
Minimum of 3 years Quality Assurance and/or other regulated industry or similar experience.
ASQ Certification as a Quality Engineer, or equivalent preferred.
Knowledge, skills and abilities (incl. languages)
Demonstrated strong organizational skills including the ability to prioritize tasks and adhere to agreed timelines
Strong technical and general problem-solving skills required.
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
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)