SENIOR QUALITY ENGINEER

  • Steripack Ireland Limited
  • SteriPack Group Ltd, Dublin Road, Petitswood, Mullingar, County Westmeath, Ireland
  • 14/07/2022
Full time, Permanent Biotech Engineering Manufacturing Pharmaceutical QA - Quality Control Science

Job Description

 

SteriPack Ireland is an Irish owned company based in Mullingar, Co. Westmeath.   We are focused on the delivery of products to Diagnostic, Healthcare and Pharmaceutical Industries. Our ISO Class 7 and 8 cleanrooms, ISO:13485 and Medical Devices Regulation (EU) 2017/745 compliance and global expertise ensure the highest class of product and best quality service to our Customers.

SteriPack’s infrastructure at Mullingar has grown rapidly from its inception in order to cater for our ever-evolving customer needs. To facilitate this growth the organization is delighted recruit for a new position of Senior Quality Engineer to evolve the site quality management system and manage, grow and develop the QA team members reporting to this key position.

 

 

Key Responsibilities

  • Select appropriate techniques for problem solving and make solid and consistent Engineering and Quality Assurance recommendations
  • Responsibility and authority to make decisions related to product quality including the disposition of non-conforming product.
  • Participate in Customer Complaints investigation for areas under your control.
  • Actively promote highest level of professional QA Engineering discipline and rigor
  • Be a leader in QSR, ISO / MDR standards within your group, be constantly aware of best industry practices.
  • Have significant expertise in validation engineering and be familiar with all regulatory requirements
  • Review and approve operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
  • Champion continuous improvement and innovation from a quality perspective within the department from vendor selection through to customer awareness/satisfaction.
  • Be an effective team member, be fully motivated to achieve and demonstrate best practices in line with the department Objectives.
  • Work with EHS to identify significant environmental impacts and help to establish goals and targets around significant environmental impacts.
  • Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise
  • Provide technical guidance to Quality Engineer, Associate Quality Engineers, technicians and inspection staff
  • Build quality into all aspects of work by maintaining compliance to all quality requirements
  • Oversees audits of all quality system categories to assess compliance to process excellence standards.
  • Ensures comprehensive measurement systems to supervise efficiency of quality and reliability systems to identify, bracket, correct and prevent defects, communicating reports to management.
  • Leads and performs upgrades to Quality System.
  • Supervise and develop others with the QA team

Qualifications and Experience:

  • Bachelor (Hetac level 8) of Engineering, Sciences or equivalent experience with a minimum of 5 years’ experience in a healthcare environment.
  • At least 5 years' experience in the Medial Device /cosmetic environment
  • Team player with strong work ethic
  • Strong written and verbal communication skills
  • People management experience is an advantage
  • Experience and/or ability to manage cross-functional team meetings; train or coach other employees; and give presentations.
  • The ability to establish rapport with internal and external customers, peers, and employees in all departments.

Excellent organizational skills.

 

 Benefits

·        Competitive salary based on experience and excellent benefits package.

·        Friendly and co-operative working atmosphere.

·        Strong career progression opportunities.

Equal Opportunity Employment

 

SteriPack Ireland Limited is committed to diversity and to equal opportunity employment.

 

KEY Competencies

People Management, Communication Skills, Work Ethic, Interpersonal skills, Engineering, Quality Assurance, ISO / MDR, Manufacturing, Validation, Science, Healthcare, Medical Device