Quality Engineer (Electromechanical Medical Device)

BioSpace; Pleasanton (CA); Presencial; USD 108 393 - 122 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Paid time off

Medical, dental, and vision insurance

401(k) plan

Resumo da oferta

A leading biopharmaceutical company in California is seeking a Quality Engineer focused on Electromechanical Medical Devices. This role involves supplier quality management, conducting statistical analysis, and ensuring compliance with FDA regulations. The ideal candidate will have a Bachelor's degree in engineering and relevant quality engineering experience in medical device manufacturing. Competitive salary and benefits included.

Qualificações

• Must have 1 year of quality engineering experience in FDA regulated medical device manufacturing.
• Experience in conducting statistical analyses for quality assessments.
• Experience in supporting quality system management and process controls.

Responsabilidades

• Manage supplier quality management cycle effectively.
• Oversee supplier audits and quality improvement initiatives.
• Conduct verification and validation for processes and products.

Conhecimentos

Statistical analysis

Supplier quality management

Cross-functional team collaboration

Formação académica

Bachelor's degree in engineering

Ferramentas

Gage Repeatability & Reproducibility

DoE

SPC

Descrição da oferta de emprego

Quality Engineer (Electromechanical Medical Device)

Join to apply for the Quality Engineer (Electromechanical Medical Device) role at BioSpace.

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Key Responsibilities

• Responsible for Supplier Quality Management cycle.
• Primary contact with suppliers on all quality related issues during both supplier maintenance & supplier selection process.
• Oversee supplier quality management activities & continuous improvement initiatives with suppliers.
• Plan & lead required supplier audits.
• Establish & maintains supplier quality metrics, scorecards, & trending.
• Generate quality plans & define risk control measures for continuous improvement.
• Conduct Design of Experiments (DOE) & Process Characterization for process optimization &/or improvement by conducting analyses using statistical techniques, including Gage Repeatability & Reproducibility (Gage R&R), Tolerance intervals, & Process Capability assessments with Cp or Cpk; lead or support design activities including design verification, validation, specification setting & justification, test method development, usability engineering, & risk management.
• Plan & conduct product & process verification & validation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ).

Qualifications

Education & Experience

Must possess a Bachelor's degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline. Must have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s).

If experience required, must have 1 year of related work experience:

• conducting analyses using statistical techniques, including Gage Repeatability & Reproducibility, Tolerance intervals, & Process Capability assessments;
• executing Installation Qualification, Operational Qualification, Performance Qualification, & Process Performance Qualification;
• supporting quality system management, process controls, & Corrective Actions/Preventative Action systems by applying essential quality tools & statistical technique including: 8D, 5-Whys, 6M, SPC, DoE, & Fishbone diagram;
• reading & interpreting mechanical drawings & GD&T
• performing daily assigned tasks in compliance with FDA's Quality System Regulation (QSR), ISO 13485, ISO 14971, MDR, & MDSAP;
• performing all tasks according to medical device development life cycles, manufacturing processes & GMP; &
• working in a cross-functional team, in a multisite corporation, preparing & delivering reports &/or presentations to scientific & business audiences, including executive team, both orally & in writing.

Work experience may be gained concurrently.

Additional Information

Salary Range: $108,393.48 - 122,000.00 per year.

Apply online at https://careers.abbvie.com/

Send resume to [e-mail]. Refer to Req ID: REF41154L

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Internet News