6 days old

Senior Manufacturing Quality Engineer

Danaher
Munster, IN 46321

Title:                      Senior Manufacturing Quality Engineer (Senior Analyst Quality Assurance)

Level:                     P3

Reporting To:       Manufacturing & Supplier Quality Manager

Responsibilities

  • Co-ordinate the Manufacturing Non-conformance process (NC) for all BCII Production areas ensuring compliance to Quality and Regulatory Standards.   
  • Lead cross functional teams providing Quality guidance and support in the determination of appropriate NC root cause analysis and implementation of effective corrective actions.
  • Responsible for the Rework process, ensuring relevant documentation is prepared, reviewed and approved as per company procedures as well as ensuring Acceptable Quality Level (AQL) inspections are completed prior to product disposition.
  • Execute the Stop Ship process for finished product released to the market, in the Oracle system, ensuring process is compliant to relevant company procedures.
  • Provide guidance and support to all departments ensuring Good Manufacturing Practices (GMP) and Quality System Regulations are complied with during the production of product.
  • Responsible for ensuring the Manufacturing Quality Procedures are current and in line with global procedures and Quality and Regulatory Standards.
  • Initiate/review/approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures.
  • Provide Quality expertise during investigations, process FMEAs and daily manufacturing issues driving process improvements as well as acting as the Quality Representative on design change projects, if applicable.
  • Review/approve Validation documentation (e.g. protocols, reports) ensuring compliance to applicable procedures.
  • Assist with the QA review & disposition of Batch History Records (BHRs) for all product lines and complete the associated ERP activities ensuring relevant logs and BHRs are maintained.
  • Participate in the BCII Internal Audit Programme as well as representing Manufacturing Quality in both Internal and External audits.
  • Support DBS improvement initiatives, utilizing DBS tools including participation in Visual Daily Management, Problem Solving and Kaizen events in Production as well as own area aimed to ensure quality, safety, productivity, on time delivery and supporting internal customers.
  • Perform CAPA (corrective and preventive action) activities and document in the Global CAPA system if required.
  • Ensure quality issues are communicated to the management team such that they are aware of any potential problems or opportunities. Additionally, generate, analyse and report quality metrics to relevant personnel and to ensure on-going improvement programmes are put in place.
  • Develop strong, positive and beneficial working relationships and effective information flow with other departments and within the Quality department.
  • Generate, update, implement and complete associated training for relevant departmental procedures, as required. Additionally, responsible for training new associates in the Manufacturing Quality group and ensuring all appropriate procedures are adhered to.
  • Assist in the Supplier Quality process acting as a Supplier Quality representative, if applicable.
  • Duties as prescribed by the Manufacturing & Supplier Quality Manager.

    • Education/ Experience:
    • Bachelor€™ s degree in chemistry, biochemistry, engineering or other relevant technical field with a minimum of 5 years€™ experience in a highly regulated (FDA desirable) healthcare or related environment, or

      Master€™s degree in chemistry, biochemistry, engineering or other relevant technical field with a minimum of 3 years€™ experience in a highly regulated (FDA desirable) healthcare or related environment, or

      Doctoral degree in chemistry, biochemistry, engineering or other relevant technical field with 0-2 years experience in a highly regulated (FDA desirable) healthcare or related environment.

    • Desirable to have previous experience in IVDDs and Manufacturing Quality.
    • Good knowledge of ISO9001/ISO13485, FDA and GMP requirements.
    • Excellent time management, planning and organisation skills.
    • Effective interpersonal and verbal/written communication skills.
    • Strong team member with the ability to identify and drive quality improvements.
    • Strong proof reading skills with emphasise on attention to detail.

      Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The €œEEO is the Law€ poster is available here.","industry":"Medical Device

Categories

Posted: 2020-05-21 Expires: 2020-06-20

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Senior Manufacturing Quality Engineer

Danaher
Munster, IN 46321

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