Quality Assurance Engineer
Há 1 mês
Life Unlimited at Smith+Nephew
We design and manufacture technology that takes the limits off living.
This position will be based in Coimbra and will be reporting to Design and Quality Engineering Manager.
The Sr. Design Quality Engineer is responsible for implementing, supporting, and sustaining elements of Smith and Nephew's quality system.
Under the guidance of the Quality Engineering Manager, they ensure that medical device regulations, standards, and guidelines are aligned with through execution of Smith and Nephew procedures.
Key Responsibilities:
- Provide quality support for manufacturing and product development processes and personnel to assure compliance with DOPs and GMP requirements.
- Support compliance and process improvement initiatives related to Operations, Engineering, and Quality functions.
- Lead the review, disposition, and correction/corrective action activities associated with discrepant components, materials, sub-assemblies, and finished products.
- Assist in the preparation and coordination of Internal and External audits to International and US standards and quality policies and procedures.
- Provide coaching and training for junior members of the quality team.
- Establish and maintain successful multi-functional relations with Materials, R&D, Engineering, Manufacturing, Marketing, IT, Finance, Sales, Quality, and Regulatory Affairs departments.
Requirements:
- Bachelor's degree in science, engineering, or other related field.
- Minimum 5 years experience in the pharmaceutical/medical device industry or related regulated industry.
- Portuguese and English proficient.
Competencies:
- Ability to make sound decisions with attention to details.
- Understanding the impact of regulatory requirements on Smith & Nephew's products is necessary.
- Must be able to provide and implement solutions to quality problems.
- Ability to plan and schedule multiple projects and tasks.
- Effective written/oral communication skills.
- Team player.
- MS Office, MS Excel, and Statistical software proficiency.
Travel Requirements:
Up to 5% domestic.
We believe in creating the greatest good for society.
Our strongest investments are in our people and the patients we serve.
Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity.
Your Future: Generous annual bonus, Save As You Earn share options.
Work/Life Balance: Meal allowance, Health insurance, Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours.
Flexibility: Hybrid Working Model.
Training: Hands-On, Team-Customised, Mentorship.
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