Quality Assurance Technician

Spellman High Voltage Electronics; Bochum; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

Spellman High Voltage Electronics is seeking a Quality Assurance professional to ensure compliance with quality standards in the medical device industry. The role involves managing nonconforming products, overseeing documentation processes, and conducting audits. Ideal candidates will have a background in engineering and experience with quality management systems.

Qualifikationen

• Several years of experience in production and/or quality assurance.
• Experience in the medical technology sector is advantageous.
• Training in Six Sigma Green Belt or Black Belt is preferred.

Aufgaben

• Owner of the SOP 804 Control of Nonconforming Products.
• Management of order, customer-specific documents, and material bookings in ERP systems.
• Evaluation of quality indicators and initiation of corrective actions.

Kenntnisse

Quality Assurance

Problem-solving methodologies

Statistical process control

ISO 9001

ISO 13485

Ausbildung

Bachelor's degree in electrical manufacturing or mechanical engineering

Tools

MS Office

Jobbeschreibung

Spellman High Voltage Electronics Corporation, a family-owned business for over 75 years, takes pride in powering progress in health, security, and quality of life. We are key partners with the world's leading medical device, semiconductor, scientific, analytics, and industrial systems manufacturers. When they want to push the limits of what's possible with high voltage applications, they turn to us to make it happen.

While Spellman is not a household name, our products are used to make and power many of the most advanced technologies that enable modern life. With design and manufacturing sites across North America, Europe, and Asia, we have become the preferred provider of high voltage power solutions for OEMs worldwide, designing and producing products that power technological progress.

Description of Function and Responsibility (Scope)

Quality assurance involves various approaches and measures to ensure that defined quality requirements are met according to the quality policy. It is not a tool for quality improvement.

Responsibilities include:

1. Owner of the SOP 804 Control of Nonconforming Products (NCP), ensuring compliance with all applicable procedures, processes, and communication with suppliers and internal teams (MA Quality Assurance).
2. Owner of the Device History Record (DHR) process related to production, including documentation, formal correctness checks, release for delivery, and maintenance of DHRs in response to changes or complaints.
3. Management of order, customer-specific documents, internal specifications, and material bookings in ERP systems, including physical handling and access control.
4. Development and execution of statistical recording, evaluation, and triggering CAPAs for nonconformities or potential issues.
5. Responsibility in the complaint process, including initial documentation, research, proper material provision, and statistical analysis of quality data, particularly concerning complaints, NCP, and DHR.
6. Implementation of qualitative requirements, conducting product and process audits, and serving as the initial contact for customer quality-related questions.
7. Evaluation of quality indicators, initiation of corrective actions, participation in risk assessments (FMEA), validation and approval of manufacturing processes, and tracking corrective actions.
8. Processing and tracking of complaints, especially related to supplier quality, and ensuring proper product release documentation.

Qualification Profile

Candidates should have completed commercial or technical training, with several years of experience in production and/or quality assurance. Experience in the medical technology sector is advantageous. A bachelor's degree in electrical manufacturing, mechanical engineering, or an equivalent field is required. Training in Six Sigma Green Belt or Black Belt is preferred.

Necessary Skills and Competencies

Required knowledge and experience include:

• Understanding of quality management systems in the medical device industry or similar.
• At least 3 years of experience with relevant quality management systems such as ISO 9001, ISO 13485, TS 16949, or similar.
• Proficiency in problem-solving methodologies like 8D, A4, DOE, or similar.
• Experience with statistical process control (SPC) and analytical evaluations (Pareto, control charts, histograms).
• Handling electronic parts and components.
• Confident use of MS Office.

We at Spellman High Voltage Electronics Corporation believe in equal employment opportunities for all, regardless of race, color, creed, gender, sexual orientation, gender identity, marital status, national origin, age, veteran status, or disability. For disability-related accommodations, please contact us via email or call 1 (631).

Note to Recruiters and Agencies: We do not accept unsolicited resumes and will not pay fees for unsolicited submissions. Resumes received will be considered property of Spellman High Voltage Electronics and processed accordingly.

Required Experience: Key Skills include Quality Assurance, Coordinate Measuring Machine, Food Industry, Food Safety, ISO 9001, Math, Food Processing, Quality Control, cGMP, QA/QC, HACCP, Manufacturing.

Employment Type: Full-Time

Experience: Several years in relevant fields

Vacancy: 1

Location: Bochum, North Rhine-Westphalia, Germany