altusafb | Quality Assurance Manager in Oklahoma City, OK

Quality Assurance Manager

  • ConvaTec
  • 821 SE 7th Ct
  • Oklahoma City, OK 73160
  • Full-Time



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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

SAP knowledge

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.


    Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task


    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.