Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments. There’s never been a more exciting time to join us. Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful. Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare. We are headquartered in Massachusetts and have centers of operation across North America, Europe, Central America, Australia and Asia. We have the strength and resources of a billion dollar company and the vision of leaders committed to a broad spectrum of health issues. We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future.
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 Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer & VEVRAA Federal Contractor