【Abbott Medical Japan】Senior QC Specialist
About this opportunity
JOB DESCRIPTION – 品質（シニア）スペシャリスト QC
Primary Function （職務概要）
製造販売する製品の品質保証及びQMS省令及びAbbott Quality Policy（AQ）に準拠した品質マネジメントシステムの構築・維持
Major Responsibilities (具体的職務内容) - - - - - - - - - - - -
製品の受入検査・ラベリング手順（包装手順書）の作成及び維持管理
- 製造記録書類の保管 - 品質文書の作成・管理（手順・記録の作成、承認管理及び保管等）
- 製品上市プロセスへの参画および必要な部門との連携
- 法定ラベルの出力設定及び関連部署と連携し表示事項の規定及び承認
- 受入検査業務委託先の管理 - 不適合品の管理（専用システムへの入力、海外製造元とのコミュニケーション及びデータ集計）
- 海外製造元からの変更情報の確認／関連部署への共有 - 内部監査、供給者監査の実施・管理 - 回収（改修）時の関連部門（安全管理グループ、ロジスティクスグループ）との連携 - 業務プロセスの改善
（Sr Specialistの場合） - プロジェクトマネージメントの経験やプロジェクトに対する積極的な参加
Minimum Requirements (必要とされる資格・経験、スキル)
Education: -
大学、短大、専門学校、高校等で物理学、化学、金属学、電気学、機械学、薬学、医学又は歯学、言語学に関する専
門の課程を修了、または上記以外の課程の場合、医療機器の品質管理又は製造販売後安全管理に関する業務に三年以上従事した者
Background: - -
基本的なPCスキル（Excel, Word, PowerPoint）
英文読解およびメールによるコミュニケーション
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 230 comparable Senior Quality roles across 59 biopharma companies.
Salary context
58 of 230 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 230 comparable roles
+ 23 more countries
Seniority mix
230 of 230 peers have a known seniority level
Therapeutic area mix
0 of 230 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.