At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access. None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities. While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
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 inclusive of disability and veterans.