Director - Chemistry Commercial Product Quality; Remote

Position: Director - Chemistry Commercial Product Quality (Remote)

Director - Chemistry Commercial Product Quality (Remote)

Join Siemens Healthineers as a remote Director of Chemistry Commercial Product Quality. Position based preferably on US East Coast.

Overview

Lead the CLS Chemistry Commercial Product Quality (CPQ) Team responsible for complaint handling, medical device reporting, and field action activities for Atellica CH, Atellica CI, ADVIA Chemistry, Dimension, and Dimension Vista Assays. Develop and execute organizational strategies, processes, goals, and metrics that drive measurable improvements in complaint handling, product quality, and customer satisfaction.

Responsibilities

• Serve as a subject matter expert for post‑market topics, processes, and tools.
• Ensure compliance with applicable regulations and standards.
• Drive product safety, quality, and customer satisfaction decisions.
• Establish short‑ and long‑term goals to improve complaint resolution, product reliability, and customer satisfaction.
• Report medical device reports on time.
• Address FDA and other NCA concerns with product recalls to achieve the best outcome.
• Train and develop team members to meet job activities and career aspirations.
• Ensure team has product and regulatory knowledge to perform jobs compliantly.
• Drive continuous improvement and excellence in KPIs.
• Foster a culture of continuous improvement, accountability, and customer focus.
• Support digitalization strategies for CPQ.
• Generate IVDR plans and reports for associated product lines.
• Collaborate cross‑functionally.

Qualifications

• Demonstrated ability to lead and manage people.
• Direct experience in the in‑vitro diagnostics industry.
• Strong communication (written, oral, listening) and problem‑solving skills.
• Strong knowledge in complaint handling, investigations, medical device reporting, field action, and CAPA processes.
• Experience covering post‑market topics in front‑room external inspections (e.g., FDA, TUV).
• Ability to balance heavy workload, customer needs, patient/operator safety and regulatory compliance.
• Strong technical knowledge of supported product lines.

Experience

• 8+ years of successful experience in related fields; detailed understanding of FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, MDSAP, and EU IVDR requirements.
• Experience in Quality Systems, MDRs and Field Action recommended.
• Advanced degree may be substituted for experience, where applicable.
• Willing to travel up to 20%.

Education

• BS/BA in related discipline, or advanced degree, or equivalent combination of education and experience.

Compensation

The base pay range for this position is $172,690 – $237,446. Factors such as geography, skills, education, experience, and other qualifications may affect starting pay.

Benefits

• Medical, dental, vision insurance
• 401(k) retirement plan
• Life, long‑term and short‑term disability insurance
• Paid parking/public transportation
• Paid time off, sick and safe time

Equal Employment Opportunity Statement

Siemens Healthineers is an Equal Opportunity and affirmative action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

Reasonable

Accommodations

Siemens Healthineers is committed to equal employment opportunity and will provide reasonable accommodations for persons with disabilities. Please fill out the accommodations form if needed.

Additional Information

For full details on benefits and benefits eligibility, please visit the company page. For privacy and data protection, follow the provided links.

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