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Product Quality Engineer (12 Months FTC)

Vacancy Title: Product Quality Engineer (12 Months FTC)
Contract Type: Permanent
Location: Manchester, Greater Manchester
Industry:
Salary: Negotiable
Start Date: ASAP
REF: J897517_1540286532
Contact Name: Ben George
Contact Email: ben.george@russell-taylor.co.uk
Vacancy Published: 25 days ago

Vacancy Description

Role: Product Quality Engineer (12 Months FTC)

Salary: Competitive

Location: North West, UK

Russell Taylor Group has a fantastic opportunity for a Product Quality Engineer on a 12 Month Contract. You will ensure that all the processes that support the Quality department including the handling of complaints, product transfers, NCRs, Quality System Investigations and CAPAs. This will be applied through the application of design control, method validation, root cause analysis, statistical techniques and risk management to ensure the continuing suitability, adequacy and effectiveness of Quality System.

Role:

  • Supports product design and development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness, through MRB, PQC
  • Ensures current and applicable good manufacturing practices (GMP) and good laboratory practices (GLP) (e.g.: ISO13485 / 21 CFR Part 820 / IVDR) to team and Manufacturing Operations staff
  • Creates documentation associated with product quality engineering activities including quality plans, test plans, protocols and reports and the update of quality system and department procedures
  • Defines technical investigations plans, reports and related procedures which ensure statistical validity, adequacy and compliance to regulatory and corporate requirements
  • Attends regular communication meetings with cross-functional teams to identify the root cause of problem and create remedial plans for short-term and long-term resolutions
  • Supports change control activities and document management requirements by collaborating with applicable departments and peers to requirements for individual project
  • Supports the transfer activities ensuring compliance with procedures and current regulatory requirements to ensure manufacturing capability / reliability
  • Applies risk management and facilitates risk assessments using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA) associated with projects
  • Ensures writing/revision or reviews and approvals required on a variety of lifecycle documents. Document types include but are not limited to; cleaning validations, QCS requirement specifications, method validations, SOPs, work instructions and forms, investigations, validation deviations (where required), CAPAs, any pertinent test data, and validation reports
  • Performs investigations and troubleshoots problems for continual improvement
  • Supports activities associated with aspects of the Quality Management System including; Status of Non-Conformances and CAPAs, Participation in Material Review Board (MRB) and Participation in compliance meetings
  • Ensures lab and working areas are in compliance with GMP, QSR & ISO requirements
  • Maintains QC material inventories, were required and ensures inventory management through ERP (Oracle) transactions
  • Performs diagnostic assay and/or amplified assay consistently with acceptable results, were required
  • Performs basic troubleshooting to resolve unexpected results when performing Diagnostic and /or amplified assays
  • Perform other related duties as assigned

Person:

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • BS or equivalent in scientific discipline, engineering, or related discipline with the required skills, knowledge and abilities that are typically acquired through experience in the in vitro diagnostics, medical device or pharmaceutical industries
  • Must be proficient in the knowledge of applicable Quality System Regulations and ISO quality requirements
  • Must have advanced knowledge of QA, Manufacturing, Method Validation, Change Control, and Design Control processes
  • Proficient in concepts of statistics, sampling plans and statistical analysis
  • Ability to independently plan, execute, and/or problem solve moderate to complex situations
  • Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Solid oral and written communication skills
  • Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation
  • Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc. effectively

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k