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Senior Quality Engineer - Medical Device (Madison, WI

Company: Mallinckrodt Pharmaceuticals
Location: Madison
Posted on: February 25, 2021

Job Description:

Senior Quality Engineer - Medical Device (Madison, WI) CC-Madison - USA503 Madison, WI Job Title Senior Quality Engineer - Medical Device (Madison, WI) Requisition JR000010981 Senior Quality Engineer - Medical Device (Madison, WI) (Open) Location CC-Madison - USA503 Additional Locations Madison, WI Job Description SummaryThe Senior Quality Engineer is responsible for leading and improving the current Quality Systems within the Madison, WI manufacturing facility. This position will have a wide range of tasks which may include manufacturing quality process development, maintenance, trending and reporting, deviation investigation, CAPA management, change management, internal/external auditing, and direct involvement and collaboration with the Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture. Principal Responsibilities

  • Develop and maintain manufacturing quality control processes for new and existing production areas
  • Develop and maintain process Failure Mode and Effects Analysis for new and existing production areas
  • Drive investigations and manage deviations and NCMRs from initiation to disposition
  • Perform and lead RCA's through cross functional team involvement
  • Manage CAPA creation and ensure adequate effectiveness
  • Perform trending of Quality Systems to support FDA and Management reviews
  • Coaching and mentoring others in regards to QMS and Quality Culture
  • Present investigations, perform risk analysis, and deliver disposition recommendations
  • Improve existing procedures to align with cGMP and regulatory requirements
  • Interpret and properly apply all applicable regulatory requirements
  • Improve quality culture through site initiatives
  • Review and approval of procedures, protocols, reports, etc--- as required.Department specific/Non-essential responsibilities:
    • Perform internal and external audits of systems and suppliers
    • Filing and management of documentation when required
    • Supporting other Quality System Functions
    • This role may be required to lead personnel (inside and outside) the Quality organization in support of the business needMinimum RequirementsExperience / Skills:
      • Bachelor's, or higher, degree in engineering or applicable science/technology program
      • 7+ years of experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred)
      • Effective communication, coaching/mentoring, and presenting skills
      • Ability to manage change
      • Self-motivated--
      • Independent and sound decision making capabilities
      • Project management to deliver on time results
      • Leadership skills / Emotional Intelligence
      • Ability to utilize statistics at a moderate level for trending and interpretation of statistical dataCompetencies:
        • Proficient with Microsoft Office tools, especially Excel
        • Technical writing
          • Statistical analysis - Minitab or other software equivalent, preferred.Organizational Relationship/Scope:The Senior Quality Engineer collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Regulatory Affairs, and Process Development. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. The position is during normal working hours M-F, but may be required to work extra hours or on weekends or holidays in order to support Manufacturing Quality activities.Working Conditions:The Senior Quality Engineer will mainly work in an office environment but will also be required to work in manufacturing and QC environments when providing QA support to those functional areas.#LI-CL1 Posted 30+ Days Ago Full time JR000010981 About Us Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. Mallinckrodt Pharmaceuticals ("the Company") maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising. Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.

Keywords: Mallinckrodt Pharmaceuticals, Madison , Senior Quality Engineer - Medical Device (Madison, WI, Engineering , Madison, Wisconsin

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