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Fresenius Kabi USA · 3 days ago
Senior Quality Engineer
Warrendale, PA
Full-time
Hybrid
Senior Level
3+ years exp
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Responsibilities
Develops supplier quality requirements and production part qualification plans for design transfers of product into the manufacturing facility.
Evaluates candidate suppliers to ensure that capabilities and systems align with capability and quality requirements.
Conducts supplier audits of prospective and selected suppliers in accordance with established procedures.
Leads technical investigations into non-conforming parts from suppliers, production, and customers.
Develops and maintains local procedures consistent with company procedures and Quality Systems Requirements.
Performs internal audits and participates in internal and external audit activities.
Initiates and manages CAPA records, collaborates with other departments and cross-functional teams to support investigations and root cause analyses, and provides well-documented corrective and preventive action plans for identified issues.
Develops statistical methods for tracking and trending requirements of products.
Prepares product performance presentations and creates dashboard reporting for management.
Leads process improvements and standardization of processes to ensure a lean manufacturing approach.
Participates in quality activities including incoming inspections, non-conformance management, First Article inspections, and evaluates suppliers’ process and product change requests.
Qualification
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Required
B.S. degree in Engineering (Mechanical, Electrical, Biomedical preferred); CQE certification a plus.
3+ years of experience in a Medical Device (21 CFR 820) related industry. Supplier Quality, quality engineering and/or Product Development experience preferred.
Working knowledge of lean manufacturing, Six Sigma, and Project Management principles a plus.
Understanding and working experience with EN ISO14971, cGMP, ISO13485:2016, ISO9001:2015, FDA Design Control, document controls.
Knowledge of quality control processes and statistical techniques.
Understanding of manufacturing processes and techniques.
Strong analytical problem-solving skills and attention to detail.
Excellent verbal and written communication skills.
Strong interpersonal skills and the ability to work with cross-functional teams.
Works under minimal supervision on complex projects and may assist with cross-training less experienced peers. Strong project management skills.
Experience with CAPA leadership and effective closure.
Ability to travel 20%.
Preferred
CQE certification
Supplier Quality, quality engineering and/or Product Development experience
Working knowledge of lean manufacturing, Six Sigma, and Project Management principles
Experience with CAPA leadership
Benefits
Medical Insurance
Dental Insurance
Vision Coverage
Life Insurance
Disability Insurance
401K with Company Match
Wellness Program
Company
Fresenius Kabi USA
Fresenius Kabi is health care company specializing in medical and medical technologies.
1,001-5,000 employees
H1B Sponsorship
Fresenius Kabi USA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (13)
2022 (19)
2021 (16)
2020 (21)
Funding
Current Stage
Late StageLeadership Team
Alex Garini
Chief Financial Officer
Sanjida Chowdhury
Vice President and Chief Compliance Officer, Region US
Recent News
Company data provided by crunchbase
