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Quality Manager, HealthTech

Date: Aug 10, 2019

Location: Galway, IE

Company: Celestica International Inc.

Req ID: 43256 
Region: Europe 
Country: Ireland 
State/Province: Galway 
City:  Galway 

About us

Celestica enables the world's best brands. Through our unrivalled customer-centric approach, we partner with leading companies in aerospace and defense, communications, enterprise, healthtech, industrial, capital equipment, and smart energy to deliver solutions for their most complex challenges. With talented teams across North America, Europe and Asia, we imagine, develop and deliver a better future with our customers.

Celestica Ireland has sites in Galway and Leixlip and are a leader in automated manufacturing services with proven expertise in delivering scalable manufacturing solutions throughout the product lifecycle.

Celestica Galway supports and provides Automated Technology Solutions & Health Tech. solutions for a number of customers including in the Medical Device space.

 

Position Summary:

Reporting into the Global Quality team, this position has site wide oversight for the Quality Management System including the role of Management Representative for any FDA manufacturing and inspections.

 

The incumbent will be a subject matter expert (SME) for medical device manufacturing and provide oversight and expertise to all Medical Device related quality policies and procedures. The incumbent will provide leadership and facilitation to cross-functional business processes that support the overall quality system.

 

This is a hands on role that requires the integration of best practice Medical Device quality processes that must conform to FDA regulatory requirements. This role will support escalations and provide input and expertise in the operational Medical Device business.

 

Key Responsibilities:

 

  • Provides the direction, coordination, education and tools needed to be compliant with FDA regulations (21 CFR, 820,807,803 as well as ISO 13485:2016).
  • Authority to escalate any significant quality non-conformances event above site management to corporate regulatory authority.
  • Leads development, implementation, maintenance and improvement of system(s) and processes that ensure the correct documentation/information/instructions are available for use and that changes are implemented correctly and in a timely manner.
  • Monitors site performance to ensure ongoing conformance to the Quality Management System.
  • Provides expert input and approvals to Master Validation Plans.
  • Leads audits from external regulatory agencies (e.g. FDA and other jurisdiction specific agencies) and customers. Incumbent leads preparation activities in advance of such audits.
  • Consultative SME on the sites Medical Device quality policies and procedures.
  • Oversight and final approver for critical activities such as CAPA, Change Control, Risk Assessment, Design, Validation, Control Plan reviews.
  • Provides training as required on quality systems, audit, eDMS and data analysis tools.
  • Creates and evaluates metrics to drive the quality improvement process.
  • Be an SME for appropriate statistical techniques to monitor process performance (e.g. SPC, Cp, Cpk, R&R analysis, sampling techniques).

 

 

Knowledge/Skills/Competencies:

 

  • In-depth knowledge of EN ISO 13485:2016.  Knowledge of the Medical Device regulations specific to manufacturing jurisdiction (EMA) and for FDA in particular.
  • Experience managing FDA Audits.
  • Knowledge of the SQE domain for medical devices and relevant auditing and inspection competency.
  • Experience in the use of techniques such as Design of Experiments, Gauge R&R, Test Method Validation, sample size justification to support design changes, validations, deviations are required.
  • Excellent customer contact, negotiation and problem resolution skills.   
  • Excellent interpersonal, written, and verbal communication skills.
  • Ability to effectively communicate & collaborate with a wide variety of internal and external customers.
  • Ability to effectively lead, manage, train and motivate a diverse group of employees to achieve desired quality results.
  • Works well on a team with proven ability in building excellent cross functional relationships
  • Ability to evaluate materials, gather and analyse data and determine root cause of problems.
  • Strong Project Management skills & ability to manage several projects simultaneously and coordinate multiple, changing deadlines.

 

Experience and Qualifications:

  • Minimum of 7-10 years’ experience in a Quality Engineering role in Medical device manufacturing – essential.
  • Involvement with minimum of 2/3 FDA inspections as the Quality Lead.
  • Degree qualification minimum in a related field – essential.
  • Lead Auditor conducting Quality Audits essential, with experience of FDA/HPRA audits highly desirable.
  • Experience of 6 Sigma methodology. Ideally a 6 sigma black belt.
  • Project Management Training/Experience – an advantage.

 

Physical Demands:

  • Travel requirements up to 20% to 40% of incumbent’s time in the short-term. Some travel long term (0-10%).

 

COMPANY OVERVIEW:
Celestica (NYSE, TSX: CLS) is a US$5.6 billion global leader in the delivery of end-to-end product lifecycle solutions. Our customers trust us to deliver the most advanced design, engineering and manufacturing expertise for their highly sophisticated and complex products. From advanced medical devices, to highly engineered aviation systems, to next-generation hardware solutions for the Cloud, at Celestica we manage the complexity for our customers and set the bar for quality and reliability in their markets. Our customer portfolio includes leaders in the enterprise computing, communications, aerospace and defense, industrial, smart energy, healthtech and semiconductor markets. Headquartered in Toronto, our global network spans 13 countries with 26,000 employees throughout the Americas, Europe and Asia.


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