Sr. PLM/Quality Analyst

  • location: Marlborough, MA
  • type: Permanent

job description

We are looking for a Senior PLM & Quality Analyst to join our IS Quality, Regulatory and R&D Center of Excellence. This individual will have a strong understanding of Quality and Regulatory processes, including Product Lifecycle Management, Audits, Training, Regulatory and Statutory Compliance, Complaints, Non-Conformance Report (NCR), Corrective and Preventative Actions (CAPA), and Supplier Quality in an FDA regulated environment.

Duties & Responsibilities:

  • Provide technical expertise in identifying, evaluating and developing systems and procedures that meet user requirements
  • Collaborate with Corporate and Divisional business partners to assess the business needs and opportunities, and to develop solutions that provide business value
  • Lead design sessions in prototyping new systems / functionalities for the purpose of enhancing business processes
  • Contribute to project plans by providing inputs to project scope, resources needed and desired outcome
  • Implement and/or modify Agile application configurations to maintain, improve, and extend existing functionalities
  • Recommend and influence business process and/or system changes to improve operational efficiency and business outcomes
  • Lead process improvement workshops
  • Communicate process and functional requirements to other work stream teams including production support, BI and infrastructure teams
  • Provide detailed functional knowledge of Agile PLM, Quality, PG&C and maintain insight to current industry best practices and how they can best be applied in Hologic
  • Responsible for maintaining the Agile application roadmap for Hologic and educating our business partners on upcoming functionality and release management


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.

  • 8+ years proven experience with Oracle Agile PLM. Oracle Agile configuration experience and SDK knowledge is required
  • Functional and technical knowledge of Oracle Agile modules (Product Cost Management, Product Governance & Compliance and Product Quality Management)
  • Strong business analysis skills
  • Experience working as part of a global team in a fast-paced environment
  • Experience developing requirements and functional designs for global technology solutions
  • Experience in the development and support of integrated business applications and systems architecture
  • Strong interpersonal, oral, presentation, and written communication skills.
  • Strong business knowledge of product lifecycle management, including item masters, bills of materials, engineering change orders, compliance and product quality processes
  • Knowledge of ERP systems (Oracle EBS is a plus)
  • At least 5-10 years of experience in Medical Device, Bio-Tech or Pharma Industry
  • Mentor and cross train other IS colleagues to support specific areas of responsibility
  • Adhere to IS policies and procedures
  • Handle multiple concurrent projects and meet deadlines
  • Knowledge of project management concepts


Bachelor's degree in computer science, management information systems, or a related field


8 plus years

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  • location: Marlborough, MA
  • job type: Temp to Perm
  • salary: $17 - $18 per hour
  • date posted: 5/16/2018