You manage quality assurance in manufacturing by overseeing product design transfers, ensuring regulatory compliance, coordinating process changes, supporting audits, and addressing non-conformities.
Anforderungen
- •5+ years’ experience as Quality Engineer
- •Strong experience with Process Validation
- •Experience handling non-conforming Products
- •Knowledge of ISO13485 and ISO14971
- •Social team player in global environment
- •Good communication skills, verbal and written
- •Hands-on and solution-oriented mentality
- •Business fluent in English and German
- •Experience with Lean management
Deine Aufgaben
- •Participate in New Product Innovation projects.
- •Ensure design output meets manufacturing requirements.
- •Review and approve deliverables per design control.
- •Ensure compliance with ISO standards and FDA regulations.
- •Coordinate process changes for market-distributed products.
- •Update quality policies and work instructions.
- •Implement risk mitigations in risk management.
- •Verify and document production processes.
- •Handle non-conforming products with relevant teams.
- •Support internal and external audits as needed.
Deine Vorteile
Meaningful work with a team
Hybrid work model
Employer-funded pension plan
Public transport ticket and devices
Informal culture and team activities
Professional training courses
Discount on Philips products
Health and sports offers
Two paid weeks for partner's birth
Free drinks and low-priced meals
Original Beschreibung
# Quality Manufacturing Engineer (m/f/d)
**Böblingen** | **Full time**
### Job Title
Quality Manufacturing Engineer (m/f/d)
### Job Description
**Your role:**
* Accompanying as a Team Member for New Product Innovation (NPI) Projects for all design transfer activities and ensure that the design output meets the established manufacturing requirements according to DMR, product Quality and Quality regulation.
* Reviews and approves deliverables in accordance with requirements outlined in the Design Control, Production Process Controls process and other applicable ISO Standards and FDA Regulation e.g. ISO 13485, ISO14971, CFR21Part820, etc.
* Accompanying Process Changes to Products in the Factory line together with other relevant stakeholders for Products which are already distributed to the Market to ensure,
* all relevant quality policies, Procedures, and work instructions of the quality management system have been updated and trained before release of the Change according to the mentioned Standards
* appropriate risk mitigations within Risk management e.g. PFMEA were considered so that the overall risk level remains acceptable before release.
* Verify that production processes for the devices, including process validation (if required) have been defined, verified, documented, and implemented.
* Handling of Non-conforming Products/Part/Material characteristics for Production area together with MRB Lead, Supplier/Manufacturing Engineering as well as Incoming inspection Team.
* Support audits as back room lead or back room team member for internal and external audits
**You are the right fit if:**
* You have 5+ years’ work experience as Quality Engineer in a highly regulated industry (preference for the medical device industry)
* You have strong experience with Process Validation methodologies combined with Risk management knowledge (e.g. PFMEA) to validate key product designs on production process level
* You have experience handling non-conforming Products, CAPAs and Quality Plans
* Knowledge and experience with application of Standards/Regulations like ISO13485, ISO14971, 21CFR820 to align QMS Processes acting as BPE as well as best supporting internal and external Audits
* You are a social team player who thrives in a global cross functional environment
* You have good communication skills verbal and in writing
* You have a hands-on and solution-oriented mentality with a high focus on Quality for product and production processes.
* You are business fluent in both English and German languages
* Experience with Lean management and problem solving
**Philips benefits for you:**
* Purpose: Doing meaningful work with a great team
* Hybrid work concept: Up to two days a week "working from home"
* Philips Pension Fund: Employer-funded pension plan
* Mobility and devices: public transport ticket, leasing bicycles, cars, and also smartphones for private use
* Culture: Informal culture, a paid day for voluntary work, various team/cultural activities (on sustainability, diversity, ...), etc.
* Philips University: Wide range of professional training courses and for personal development
* Philips MyShop: Discount on Philips products
* Philips in Balance: Various offers for physical and mental health and sports courses
* “Partnerzeit” – two paid weeks off after your partner has given birth
* Meals: Free drinks and low prices in our canteen and Café Philistro