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Be a member of bqs. certification bodies

Currently hiring for following positions
Quality management system ISO 13485 assurance auditor | lead auditor
Position type

Permanent | Part time | Contracted

Location

Slovakia | Home based per world region | Willing to travel 70% of time

Role duties and responsibilities
  • review and assessment of QMS documentation
  • planning and management of audit according to ISO 13485 and other relevant certification schemes
  • performance of audit on site at location of client premises (including coverage of all client shifts) according to bqs. certification procedures and related certification schemes
  • collection and analyse of sufficient objective information to provide a recommendation for certification body decision
  • client`s CAPA evaluation and verification
  • audit team leadership
  • audit team members tasks assigning and performance verification
  • mentoring of auditors and auditors under training
  •  attending join audits with other certification schemes and integrated management system audits
  • management system assessment support for other bqs. departments (e.g. product assessment, trainings)
  • active cooperation on certification schemes and standard development and reviews
Role requirements
  • relevant qualification according to technical areas described in IAF MD 9 document
  • previous work experiences with auditing according to ISO13485 | ISO 9001 | 93/42/EEC | 98/79/EC
  • certified auditor
  • post-secondary education or relevant work experiences in at least one of the following areas
    • biology or microbiology
    • chemistry or biochemistry
    • computer and software technology
    • electrical, electronic, mechanical or bioengineering
    • human physiology
    • pharmacy
    • physics or biophysics.
  • four years of full-time work experience in medical device related industry,  including at least two years of work experience in one or more of the following:
    • closely related industries and the workplace such as research and development, manufacturing
    • the application of the device technology and its use in health care services and with patients
    • testing the devices concerned for compliance with the relevant national or international standards
    • conducting performance testing, evaluation studies or clinical trials of the devices
Environment management system ISO 14001 assurance auditor | lead auditor
Position type

Contracted

Location

Home based per world region | Willing to travel 70% of time

Role duties and responsibilities
  • review and assessment of EMS documentation
  • planning and management of audit according to ISO 14001 and other relevant certification schemes
  • performance of audit on site at location of client premises according to bqs. certification procedures and related certification schemes
  • collection and analyse of sufficient objective information to provide a recommendation for certification body decision
  • client`s CAPA evaluation and verification
  • audit team leadership
  • audit team members tasks assigning and performance verification
  • mentoring of auditors and auditors under training
  •  attending join audits with other certification schemes and integrated management system audits
  • active cooperation on certification schemes and standard development and reviews
Role requirements
  • relevant qualification according to technical areas described in IAF MD 9 document
  • previous work experiences with auditing according to ISO14001 | ISO 9001
  • certified auditor
  • post-secondary education or relevant work experiences in at least one of the following areas or similar:
    • Environmental Science
    • Environmental Management
    • Natural Resource Management
    • Environmental Engineering
    • Environmental Assessment
In vitro diagnostic medical device Technical expert/assessor 98/79/EC
Position type

Permanent | Contracted

Location

Slovakia | Home based per world region | Willing to travel 30% of time

Role duties and responsibilities
  • assessment of technical documentation related to technical aspects of design, construction and production of the device and associated risks, safety and device performance according to 98/79/EC, common technical specifications and recognized standards
  • assessment of achievements of criteria set by applied directives and related standards
  • provide scientific evaluation and its result and draw up comprehensive report on such evaluation
  • performance of audit on site at location of client premises according to bqs. certification procedures and related certification schemes
  • collection and analyse of sufficient objective information to provide a recommendation for certification body decision
  • client`s CAPA evaluation and verification
  • attending join audits with other certification schemes and integrated management audits
  • active cooperation on certification schemes and standard development and reviews
  • cooperate and communicate with lead auditor and other team members during on-site (audits) and off-site (preparation prior audit) assessment activities and provide expertise support to members of audit team or to certification body assessors evaluator
Role requirements
  • post-secondary education or relevant work experiences in at least Master degree at least in one area determined by NBOG 2009-3, most likely in
    • medicine technic, medicine, veterinary medicine
    • biology, microbiology
    • toxicology, pharmacology, pharmacy
    • chemistry or biochemistry
    • material or biomaterial science
    • bioengineering, electro-technic, mechanics
    • software coding
    • physics, biophysics
  • 4 years work experiences related design, production, quality control of in vitro diagnostic medical device, testing laboratories, research centers, universities, certification bodies or similar
Medical device Technical expert/assessor 93/42/EEC
Position type

Permanent | Contracted

Location

Slovakia | Home based per world region | Willing to travel 30% of time

Role duties and responsibilities
  • assessment of technical documentation related to technical aspects of design, construction and production of the device and associated risks, safety and device performance according to 93/42/EEC and recognized standards
  • assessment of achievements of criteria set by applied directives and related standards
  • provide scientific evaluation and its result and draw up comprehensive report on such evaluation
  • performance of audit on site at location of client premises according to bqs. certification procedures and related certification schemes
  • collection and analyse of sufficient objective information to provide a recommendation for certification body decision
  • client`s CAPA evaluation and verification
  • attending join audits with other certification schemes and integrated management audits
  • active cooperation on certification schemes and standard development and reviews
  • cooperate and communicate with lead auditor and other team members during on-site (audits) and off-site (preparation prior audit) assessment activities and provide expertise support to members of audit team or to certification body assessors evaluator
Role requirements
  • post-secondary education or relevant work experiences in at least Master degree at least in one area determined by NBOG 2009-3, most likely in
    • medicine technic, medicine, veterinary medicine
    • biology, microbiology
    • toxicology, pharmacology, pharmacy
    • chemistry or biochemistry
    • material or biomaterial science
    • bioengineering, electro-technic, mechanics
    • software coding
    • physics, biophysics
  • 4 years work experiences related design, production, quality control of in vitro diagnostic medical device, testing laboratories, research centers, universities, certification bodies or similar
Medical device Clinical expert 93/42/EEC
Position type

Permanent | Contracted

Location

Slovakia | Home based per world region | Willing to travel 30% of time

Role duties and responsibilities
  • assessment of technical documentation clinical aspects and impact of medical device under assessment related to its safety and performance according to 93/42/EEC and recognized standards
  • assessment of achievements of criteria set by applied directives and related standards
  • provide clinical evaluation and its result and draw up comprehensive report on such evaluation
  • client`s CAPA evaluation and verification
  • cooperate and communicate with lead auditor and other team members during assessment activities and provide expertise support to members of audit team or to certification body assessors evaluator
  • cooperate and communicate with evaluator during assessment activities and provide expertise support in case of need raised by any member of assessment team
Role requirements
  • master degree at least in one area determined by NBOG 2009-3, most likely in
    • medicine
    • veterinary medicine
    • biology
    • toxicology
    • chemistry or biochemistry
    • material or biomaterial science
  • 4 years work experiences related to health sector
  • at least 2 years in hospital or relevant clinical practice
  • practical experience with assessment or performance of clinical investigation or clinical data or ongoing active clinical practice

Impartiality approach at all levels of bqs. certification bodies

our mission

to assure protection and safety of the European and Worldwide market, patients, consumers and end users by our thorough supervision over products and their manufacturers who are able to pass national and our strict safety and quality requirements by which we enhance trust in our work and in our clients.

our vision

be the most trusted company in provided service  segment and be one of the strongest competitive players of traditional well established certification bodies, notified bodies and testing houses. Build the strong, trusted and well known trademark bqs. as a safety and quality assurance symbol.

our milestones

  • gain authorization and notification for product assessment according to the european directive:
    98/79/EC – In Vitro medical devices
    93/42/EEC – Medical devices
    2009/48/ES  – Toys
    2014/35/EU – LVD
    2014/30/EU – EMC
  • build up powerfull assurance brand name
  • build up complex in-house testing center
  • establish company branches in Middle East, India, China and Indonesia region
  • provide one application in-house certifiction solution