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Global Project Manager - Software Quality - Health Tech (Remote)

Date: Feb 11, 2021

Location: Remote Employee US, US

Company: Celestica International Inc.

Req ID: 68692 
Region: Americas 
Country: USA 
State/Province: New Hampshire 
City:  Remote Employee US 

 

At Celestica, we value quality above all else. We are committed to raising the bar and exceeding our customers’ expectations. We never settle. We leverage our leadership. We’re nimble problem solvers. We hold ourselves to the highest standard. We’re committed to improving and maintaining an effective quality management system as a framework for setting quality objectives that support the company’s strategic direction.

 

Position Overview:

 

We are currently seeking a Global Project Manager for Software Quality in our Health Tech division to join our global Quality team to lead our expansion into the Health Tech market, with impeccable product and process quality. The successful candidate will have significant experience in FDA and Software processes and will lead the efforts of multiple support organizations globally to ensure successful engagements with Celestica’s customers, suppliers and other partners in the Health Tech arena.

 

This is a Remote position that can be home based or at an existing Celestica site anywhere in the US with good access to an airport.

 

Responsibilities:

  • Support the Computer System Validation program for Celestica's Health Tech market segment (medical devices, diagnostics). 
  • Partner with Global IT and Business to ensure Health Tech software validation requirements (21 CFR 820, 21 CFR Part 11, EU Annex 11, ISO 13485, ISO 14971, IEC 62304, MDSAP, EU MDR/IVDR, applicable software validation guidance’s) and other applicable regulations are met. 
  • Act as Quality Lead in global Computer system validation project meetings to provide QA perspective, guidance, and review and approval of computer system validation documentation and change control impacting Health Tech processes.
  • Adhere to project schedules as applicable to set role and responsibilities.
  • Coordinate Quality software reviews and training with Health Tech sites and advise management of potential risks along with mitigation plans and recommendations related to software validation compliance.
  • Drive Quality “Audit Ready” Culture with the Health Tech sites to ensure an effective system of internal audits is in place and development of internal and supplier auditors across the network as well as supporting external audits (i.e. Notified Bodies, Suppliers) for software processes.
  • Conduct audits of Health Tech sites and/or suppliers as required to monitor compliance and support external audit’s execution for software processes as Quality Subject Matter Expert.
  • Support the Health Tech sites with quality guidance to document software quality issues as well as the actions taken to effectively resolve these issues through 8D methodology to comply with CAPA process.
  • Drive continuous improvement to validation software, processes and capabilities to improve overall quality, compliance and efficiency.
  • Conduct Quality software training to develop and train Health Tech’s global personnel as required.
  • Provide quality program management leadership and support for special projects and/or initiatives as required, as well as guidance and leadership to various Quality communities and other internal teams.

 

Knowledge, Skills, & Abilities:

  • Strong knowledge of Quality Management System’s regulations and standards for medical devices and diagnostics in Health Tech (e.g. 21 CFR 820, 21 CFR Part 11, EU Annex 11, ISO 13485, ISO 14971, IEC 62304, MDSAP, EU MDR/IVDR, applicable software validation guidance’s).
  • Experience shall include validation of Computer Systems Validation methodologies, investigations, change control, and risk management in a medical device manufacturing environment. 
  • Thorough understanding of validation principles and testing procedures with solid analytical, statistical and problem solving skills for computer systems and software.
  • Ability to evaluate, prioritize and problem solve a variety of tasks to ensure their timely and accurate completion of tight timelines.
  • Outstanding relationship management and interpersonal skills with ability to communicate, motivate, lead, and manage internal and external customers.
  • Experience on Client/Server applications; Quality Management Systems (EtQ or equivalent); ERP systems (SAP), e-Validator, Equipment Control validation (PLC/SCADA), SQL Server applications, Network and Enterprise Content Management Systems is preferred. 
  • Strong Microsoft Office skills with ability to conduct complex data analysis, detailed status charts, reports and presentations.
  • Excellent knowledge and understanding of medical device’s design, manufacturing, quality, and business processes in a rapidly changing environment.
  • Knowledge of Software Testing Tools is preferred. 
  • 10- 25% Travel.

 

Experience:

  • 7-10 years with leadership experience in software quality management and/or related functions, including experience in Manufacturing Quality, Design Quality, Validation, Quality Assurance and Quality Systems. 
  • 5 years+ experience in the Health-Tech business.
  • Computer validation experience in health science industry required
  • A minimum of 5 years’ experience conducting quality audits for both internal and external stakeholders (e.g. FDA, Notified Bodies, Customers, Suppliers).
  • In-depth knowledge of Quality Management Systems, IT, software validation, and demonstrated experience in managing compliance in various countries.
  • Global and multi-site project management experience in software.
  • Prior experience in driving cultural change initiatives in medium-to-large organization to drive Quality awareness in software processes.

Education:

  • Bachelor’s degree in Engineering or Science related field or consideration of an equivalent combination of education and experience. 
  • RAC(US), CQA ASQ, CSQE ASQ, or ISO/RABSQA Auditor Certification an asset, but not required.

 

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Celestica’s policy on equal employment opportunity prohibits discrimination based on race, color, creed, religion, national origin, gender, sexual orientation, gender identity, age, marital status, veteran or disability status, or other characteristics protected by law.

This policy applies to hiring, promotion, discharge, pay, fringe benefits, job training, classification, referral and other aspects of employment and also states that retaliation against a person who files a charge of discrimination, participates in a discrimination proceeding, or otherwise opposes an unlawful employment practice will not be tolerated. All information will be kept confidential according to EEO guidelines.


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