Quality Assurance Manager
ConvaTec
United Kingdom
7d ago

QA Manager role manages all aspects of Quality Assurance and including the overview of validation processes. Also, responsible for maintaining a state of audit readiness by maintaining Quality System records.

Responsible for the Product release, manufacturing quality engineering, and operational QA. This role will cover Deeside and Rhymney QA operations

Duties and Responsibilities

Responsible for the QA team, actively leading, mentoring and supervising.

Maintains an excellent up to date knowledge of international Quality Regulations and advises management of implications for the site.

Represents Quality on the more complex projects that require coordination of several quality resources.

Works closely with other functions on site, including manufacturing and engineering, to communicate and implement relevant Quality Systems.

Supports inspections by regulation bodies, including BSi.

Proficient in CEDAR, SAP, Trackwise and spreadsheet / database software.

Enhances procedures to inspect and report quality issues

Supports the Internal Audit processes

Key representative for Global QA operations.

Actively supports NC and CAPA to ensure timely actions

Monitors all operations that affect quality

Supervise and coaches QA teams, Operations, Engineering, technicians and other staff

Assure the reliability and consistency of production by checking processes and final output

Reports all malfunctions to senior management to ensure immediate action

Facilitate proactive solutions by collecting and analyzing quality data

Review current standards and policies

Keep records of quality reports, statistical reviews and relevant documentation

Communicates with external notified bodies during on-site inspections

Using relevant quality tools and making sure managers and other staff understand how to improve the business.

Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, corrective actions, and re-validations

Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints and internal investigations.

  • Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures;
  • establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.

  • Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence;
  • determining operational and performance qualification; writing and updating quality assurance procedures.

    Accountable for raising of Non-conformances and activities associated to CAPA

    Accountable for all intermediate and finished product release

    Deputy for Management representative

    Travel Requirements

    Yes sufficient time spent at both Deeside and Rhymney sites to ensure correct level of support

    Education / Experience / Qualifications

    Degree, or equivalent, in Science or Engineering

    Qualification in Quality Management

    Demonstrated experience in Pharma / Medtech industry

    Regulatory and compliance knowledge of Validation

    Knowledge and experience of working with a Quality Management System within Medical Device manufacturing

    Background in direct Management or supervision

    Experience of QA operations

    Requirements :

    In depth knowledge of the regulations in 21CFR 820 and 803 as well as ISO13485 & 9001

    Knowledge and experience in Corrective and preventative actions

    Knowledge and experience in the Change Control, validation and NSPR processes.

    Knowledge of ConvaTec business systems namely CEDAR, Trackwise and SAP

    Knowledge of ConvaTec product lines and documentation systems

    Broad knowledge of Quality Systems to enable facilitation of cross-functional teams

    Excellent Report / presentation writing skills

    Strong interpersonal skills

    Strong analytical skills

    Experience of database and associated reporting skills

    Awareness of sterilization principles

    EDMS systems knowledge

    Desirable but not required :

  • Six Sigma trained is preferable
  • ConvaTec offers a competitive salary along with a comprehensive employee benefits package including private healthcare, Share Save scheme, enhanced Pension and a variety of other components.

    ConvaTec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

    Notice to Agency and Search Firm Representatives : ConvaTec is not accepting unsolicited resumes from agencies and / or search firms for this job posting.

    Resumes submitted to any ConvaTec employee by a third party agency and / or search firm without a valid written and signed search agreement, will become the sole property of ConvaTec.

    No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

    If you are an active employee at ConvaTec, please do not apply here. Go to the Career Worklet on your Workday home page and View "ConvaTec Internal Career Site - Find Jobs". Thank you!

    At ConvaTec, we exist to improve the lives of the people we touch. We are committed to helping people with chronic health conditions lead the life they want giving them more mobility, confidence and freedom.

    Our customers depend on our advanced technologies to help reduce potential complications of skin breakdown and infection, and they rely on our products and services to help manage their conditions every day.

    Meeting their needs is what motivates us and is a source of tremendous pride for our nearly 9,000 employees.

    Our vision is to be recognised as the most respected and successful MedTech company, worldwide. To achieve this, we drive for excellence in all that we do anticipating and addressing our customers’ needs with advanced technologies and best-

    in-class products and services.

    Our values-based culture helps drive our success.

    Caring for People : We are passionate about improving people’s lives and put people at the centre of everything we do.

    Driving Innovation and Excellence : We are dedicated to finding innovative solutions that anticipate and address our customers’ needs and to delivering best-in-class execution.

    Earning Trust : We earn trust by delivering quality products and services that our customers can rely on. Our personal actions underpin this trust we do what we say we will do.

    If you would like to know how we intend to use your data following your application please refer to our full data privacy policy on the following link : https : / / www.

    convatecgroup.com / privacy-policy /

    If you are an active employee at ConvaTec, please do not apply here. Go to the Career Worklet on your Workday home page and View "ConvaTec Internal Career Site - Find Jobs". Thank you!

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