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

Qualifications:

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

Education:

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

Experience:

8 plus years

get jobs in your inbox.

sign up
{{returnMsg}}

related jobs


    Assembler

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