We are now seeking Principal Engineer, Supplier Quality to join our Supplier Quality team in Helsinki. As a Principal Engineer, Supplier Quality you would be responsible for supporting the Supplier Quality function within the Consumables and Ventilation business units (i.e. new supplier qualification/ assessment, design or product transfer, and monitoring/measuring/developing the existing supplier base) working cross functionally with multiple internal stakeholders and external suppliers. This position will be a new permanent employment position due to the coming new projects.
You need to have
- A minimum of two to four (2-4) years’ experience of manufacturing or managing contract manufacturers of electronics and/or electromechanical HLAs – preferably in medical device industry
- A minimum of two to four (2-4) years of relevant professional medical device experience in the following areas: Quality/Supplier Quality Engineering, Quality System or Process audits as lead auditor, medical device manufacturing, design transfer, process validation (IQ, OQ, PQ), statistics and sampling methods, and CAPA process.
- Familiarity about the general design assurance and regulatory requirements in medical device industry (FDA QSRs, ISO 13485, ISO14971, MDSAP, MDD/MDR)
- Analytical mindset
- Capability to manage details while seeing the big picture
- Flexible, diligent and hardworking attitude
- Strong team playing capability
- Excellent communication and documentation skills in English
- Ability to travel up to 15% (domestic and international)
Good to have
- Knowledge of software development
- Familiarity with Statistical software (MiniTab)
- Familiarity with TQM and/or Six Sigma Methodology
- Lead new supplier qualification/assessment of finished goods, components, raw materials, and/or services.
- Auditing suppliers as lead auditor
- Lead design or product transfer and process validation (IQ, OQ, PQ) activities.
- Monitor/manage existing contract manufacturers, private label, joint label and OEM suppliers to verify adherence to product requirements and ensure compliance with applicable FDA and International regulations.
- Responsible for reporting quality trends and information to management on the performance of suppliers
- Perform supplier improvement initiatives to enhance product quality and supplier regulatory compliance.
- Effectively able to management tight deadlines with multi-suppliers and -tasks simultaneously.
- Support the development of policies, procedures, quality plans, and methods for the governance of supplier quality activities.
- Support the execution of corrective and preventive actions to issues relating to process and/or product quality.
- Work with Suppliers and Internal functions to resolve complaints related to supply product,
- Assist the Business Unit and Plant Management Representatives in preparation for third party audits (i.e. FDA inspections & notified body audits) and in the effective closure of findings resulting from such audits.
We offer you
- Exciting projects to improve patient outcomes
- Place in fast growing organization in global company
- Central location in Vallila, Helsinki
- Great work atmosphere
- Opportunity to take responsibility of bigger entities
Please apply by sending a cover letter and CV via Monster announcement or email to email@example.com by 02.07.2021. State “Principal Engineer, Supplier Quality” subject field. If you have any questions about the position please contact: Ilkka Lehmusvirta on tel. +358 (0)44 338 3744 (preferably Mon, Wed, Fri between 12:00-13:00).
We aspire to a “higher calling”, aligning ourselves with healthcare providers to improve the lives of those who are treated with our devices.
Across the Ventilation, Respiratory Diagnostics and Anesthesia Delivery & Patient Monitoring market segments, we represent the largest pure-play company of our kind, with an ambitious and innovative vision for growth. We hold each other mutually accountable for the quality and reliability of our products and work together toward setting a new market standard in these categories.
We are transforming the future of respiratory care; explore how you can be a part of it.
We are a unified “breathing company”, with a global team that is unrivaled in the respiratory care continuum. Each of our 5,000 people worldwide is critical to achieving our shared purpose of improving the lives of those who are treated with our devices. Our people are empowered to “do the right thing” every day and always put patients first. Our market presence, breadth of product and technical expertise enable us to impact the lives of patients around the world every day.
One of our unique strengths is the diversity of our community. We want to treat each teammate fairly and provide equal employment opportunities regardless of a person’s race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic.