Shire Jobs

​10 - Manager, Operations Quality 2

Req ID: 122144

Remote Position: No

Hiring Manager: James McHugh

Band: 10

Region: Europe

Country: Ireland

State/Province: Galway

City: Galway

General Overview

Functional Area: Quality (QUA)

Career Stream: Operations Quality (OPQ)

Role: Manager 1 (MG1)

Job Title: Manager, Operations Quality 1

Job Code: MG1-QUA-OPQ

Job Level: Band 09

Direct/Indirect Indicator: Indirect

Summary

Reporting into the site GM, the role of operations quality manager is to manage and provide direct and indirect supervision to skilled and intermediate-level professional employees performing diverse roles within the quality function or unit. Provide direction, coordination, and the tools needed to achieve and maintain the site Quality Management System and enable the achievement of quality objectives.

Additional responsibility in the role may be assigned and includes elements such as leadership and facilitation to cross-functional business processes that support the overall quality system.

Detailed Description

Your next challenge will be to…

• Supports generation of performance metrics for products and processes of moderate complexity, and drives the team to achieve Quality Goals set by management (i.e.: DPQL, Total Quality at Celestica (TQ@C)), following industry standards such as ISO, IPC, AS, TL

• Leads Quality Improvement Programs (QIP) in support of customer requirements and expectations that are considered medium in scale and moderately complex.

• Directs and influences the preparation of documentation to support high quality regulatory submission dossiers.

• Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed.

• Acts as company representative, developing and maintaining positive relationships with the device owners through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.

• Mentors and trains personnel in the practices of Quality management and Quality improvement (succession development)

• Resolves customer issues of moderate difficulty using quality tools: Root Cause Analysis and Corrective Actions that are effective and timely.

• Provides leadership and support in a variety of areas such as, analysis of nonconforming materials and customer return material authorizations. (RMA's), supporting customer and 3rd party audits, and the administration of Quality management (Documentation, Change Control, Corrective & Preventive Actions and Calibration)

• Supports new customer qualification and New product introduction with supplier assessments, First Article Inspections and oversee generation of product documentation for products / programs of moderate risk

What do we offer:

• Market-competitive total reward: flexible salary, fix and variable salary based on goals

• The opportunity to become a key member of the new product introduction team in the Health Tech Quality function driven by innovation where creativity matters.

• Training and development opportunities, with us the sky is the limit!

• The opportunity to innovate, learn, mentor others and work toward your own vision of career success

• A global, collaborative culture with strong leadership imperatives to foster your growth and professional opportunities

• A sustainable culture where we provide opportunities for employees to give back to the community.

Knowledge/Skills/Competencies

What do we expect from you?

• In depth knowledge of quality metrics, ISO standards and processes.

• Knowledge of Lean and Six Sigma Manufacturing processes and controls including: Statistical Process Control (SPC), 5S and Value Stream Mapping (VSM)

• Strong knowledge of Quality Management tools including: Failure Mode and Effect Analysis (FMEA) and development of Quality Control Plans

• Ability to coordinate a wide variety of resources to meet production quality and quantity metrics.

• Ability to effectively communicate with a wide variety of internal and external customers.

• Ability to effectively lead, manage, train and motivate a diverse group of employees to achieve high production levels within tight time deadlines and in a highly dynamic manufacturing environment.

• Ability to use some or all of the following PC applications: Google Applications, Word, Excel, and PowerPoint.

• Excellent knowledge of the manufacturing processes

Typical Experience

What are we looking for?

• Minimum of 7-10 years’ experience in a Quality role

• 2 – 5+ years regulatory affairs experience or related experience in medical device industry and/or Pharmaceuticals is required.

• Working knowledge of FDA and international regulations

• Experience working directly with FDA, notified bodies and/or international health authorities is desired.

• Degree qualifications (NQF L8 or L9) minimum in a related field or consideration of an equivalent combination of education and experience.

Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).

At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.

COMPANY OVERVIEW:

Celestica (NYSE, TSX: CLS) enables the world’s best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.

Celestica would like to thank all applicants, however, only qualified applicants will be contacted.

Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.