Most QA, RA Candidates Lack Some Desirable Qualities

Erik Swain

April 1, 2008

2 Min Read
Most QA, RA Candidates Lack Some Desirable Qualities

NEWS TRENDS

Mandatory Skills


Professional appearance and behavior (143)
Good technical skills (163)
Good verbal skills (166)
Good writing skills (180)
Sufficient experience for job level (124)

Desirable Skills


Leadership potential (161)
Sense of humor (118)
Knowledge of product under development (121)
Knowledge of FDA requirements (119)
Knowledge of ISO requirements (128)
Positive track record at other firms (122)
No unexplained gaps in employment history (109)
Presently located in the area (119)
Industry certifications (RAPS, ASQ) (125)

Optional Skills


Knowledge of a foreign language (110)
Graduate degrees (116)


Technical skills, writing skills, and verbal skills are among the most important characteristics that medical device firms look for when hiring entry-level quality and regulatory personnel, according to a survey. Yet, according to the same survey, the majority of interview candidates lack good writing skills and knowledge of FDA and ISO requirements.

Compliance-Alliance LLC (Arlington, VA) conducted a survey of 395 individuals looking to hire medical device quality and regulatory personnel. The skills that at least a plurality of them deemed as mandatory for entry-level applicants were:

  • Good writing skills.

  • Good verbal skills.

  • Good technical skills.

  • Professional appearance and behavior.

  • Sufficient experience for job level.

A plurality of them deemed most of the other characteristics listed as desirable but not mandatory. These included leadership potential, knowledge of ISO and FDA requirements, knowledge of the hiring firm's products under development, industry certifications, and positive track records at previous employers.

Most respondents did not deem knowledge of a foreign language or possession of graduate degrees to be all that important for entry-level candidates.

When asked which characteristics are lacking in the majority of applicants seen, respondents most commonly said:

  • Knowledge of firm's products under development.

  • Sufficient experience for job level.

  • Leadership potential.

  • Knowledge of ISO and FDA requirements.

  • Possession of industry certifications.

  • Good writing skills.

Although a number of entry-level candidates don't have some of the skills that device employers most demand, neither do employers tend to have internship programs that can help develop those skills. Only 13.4% of respondents said their firms had formal internship programs. On the positive side, 70.6% said their firms have a tuition reimbursement program for graduate education.

When asked to list what skills can make a candidate competitive, quite a few respondents named adaptability and creativity—but within the boundaries of compliance, not to an extreme extent.

Copyright ©2008 Medical Device & Diagnostic Industry

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