Quality Manager - Oral Care Business Unit [Ranir]

Quality Grand Rapids, Michigan


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

SUMMARY:

This role will provide leadership, direction and hands-on involvement in the development and implementation of an FDA and ISO compliant Quality Management System (QMS). This leadership position will be responsible for providing management-level leadership to quality assurance, engineering, compliance and audit, and control teams involved in the global commercialization of medical devices, OTC drugs, cosmetics and consumer products.

This role will act as key partner to collaborate with regulatory affairs, supply chain, operations, marketing, and research & development to provide guidance in interpreting regulations, standards, customer requirements and internal policies to ensure facility-wide understanding and consistent implementation.  

RESPONSIBILITIES:

  • Serve as the Management Representative. Ensure that processes needed for the QMS are documented; report to top management on the effectiveness of the QMS and any need for improvement; ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
  • Implement and sustain an FDA and ISO compliant quality system appropriate to products and target geographies
  • Identify quality projects designed to achieve departmental and organizational objectives
  • Define and establish targets aligned with the company’s overall strategic goals. Monitor and analyze company’s performance to targets and initiate actions to address deficiencies
  • Provide "expert" level knowledge, training and consulting on Quality/ Regulatory topics
  • Manage and develop direct QA staff and other functional areas as needed to successfully manage communication and change management related to QA initiatives
  • Successfully support departmental cost-savings and continuous improvement objectives
  • Provide correspondence in response to quality issues, inquiries, or requests. Interpret customer specifications and requirements to ensure conformance
  • Perform due diligence activities in association of mergers and acquisitions; develop and execute integration plans
  • Collaborate directly with R&D, Marketing, Sales and legal and regulatory experts to support new product development and product innovation
  • Manage organization to support overall strategy and business growth
  • Achieves financial objectives by preparing the quality assurance budget; scheduling expenditures; analyzing variances; initiating corrective actions 

ESSENTIAL KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

  • Bachelor’s Degree from an accredited institution in engineering, Life Science, Engineering, or Physical Science or related field of study required; Masters preferred
  • Minimum 7 years’ experience working within a QMS or manufacturing organization; experience in a medical device required
  • Minimum 4 years’ experience managing a team of professionals in a quality assurance or operations environment
  • SAP experience strongly preferred
  • Demonstrated success working with external quality and regulatory organizations (e.g. ASQ, RAPS, TOPRA) with an understanding of regulatory requirements
  • Demonstrated success in process validation with equipment / instrument qualification experience; working knowledge of process controls, control plans, and risk management tools
  • Advanced experience in one or more quality-related areas – e.g. advanced metrology, laboratory controls, internal / external audits, reliability engineering
  • Experience supporting and leading FDA inspections or other comparable audits is required
  • CQE or CQM and CQA certification is preferred
  • A thorough knowledge of FDA Quality System Regulations, ISO 13485, 21 CRF 211, Medical Devices Directives and other applicable International Standards are required
  • Working knowledge of Lean Principles, 5S, Six Sigma; ability to lead projects and demonstrate competency utilizing these tools
  • Expert-level proficiency with PC skills such as Word, Excel, PowerPoint and with the ability to quickly learn various in-house software applications as needed
  • Ability to communicate effectively (written and verbal) with associates and internal and external stakeholders; demonstrated ability to work with senior leadership, multi-national or virtual teams, and frontline organization
  • Proven ability to manage multiple high priority items and drive strategic activity resulting in achievement of organizational goals
  • Proven ability to manage and motivate associates to accomplish objectives; knowledge of people management skills to influence others and resolve conflict
  • Proven ability to coach and develop direct and indirect team members, acting as partner, educator and mentor throughout

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.