Quality engineer ii, medical device

quality engineer ii, medical device.

new haven , connecticut

posted today

job detailssummary

$60 - $62 per hour

contract

bachelor degree

category computer and mathematical occupations

reference1014546

job detailsjob summary:Position SummaryAs part of the Medical Device team, the Quality Engineer II shall support lab quality assurance activities for equipment qualification, test method development and design verification and validation testing. They shall also provide quality oversight for the review and approval of key Design History File and Risk Management file deliverables to support design control activity of clinical and commercial combination products. This position will report to Director of Medical Device Quality. The successful candidate shall work on site a minimum of 3 days per week at the New Haven site location.location: New Haven, Connecticutjob type: Contractsalary: $60 - 62 per hourwork hours: 8am to 4pmeducation: Bachelorsresponsibilities:Position SummaryAs part of the Medical Device team, the Quality Engineer II shall support lab quality assurance activities for equipment qualification, test method development and design verification and validation testing. They shall also provide quality oversight for the review and approval of key Design History File and Risk Management file deliverables to support design control activity of clinical and commercial combination products. This position will report to Director of Medical Device Quality. The successful candidate shall work on site a minimum of 3 days per week at the New Haven site location.Principal Responsibilities

Provide Quality oversight to ensure quality processes are in place for the qualification of lab equipment and fixtures prior to use for GxP activity.

Responsible to ensure device testing, method development, method transfers and troubleshooting and all related documentation is compliant to applicable regulations.

Reviews and approves characterization, feasibility studies, test method development/validations, equipment qualifications activities (FAT/SAT/IQ/OQ/PQ) in compliance oversight per FDA 21CFR 820.30 and ISO 13485.

Actively participates in test method development, and transfer meetings to other labs representing the qualify assurance function to ensure compliance with procedures.

Support the development of Plans for development, verification/validation, technology transfer and risk management in line with applicable regulations for combination products,

Provide Quality oversight for the development, review, and approval of key Design History File deliverables including Verification and Validation Protocols and Reports, Risk Management deliverables, Transfer Plans, Design Reviews, Design History File management and supporting operational procedures.

Supports root cause investigations, provides compliant options for resolving lab technical and quality issues (lab investigation reports), in compliance with QMS and regulatory expectations.

Reviews and approves Lab Investigation reports, method related deviations and/or CAPAs.

Analyse, trend, and report data supporting design verification/validation, clinical and commercial release.

Draft, reviews, and approves Quality Agreements (QAG) for equipment vendor, method developers, and service providers.

Other duties as assigned.

Qualifications

Must have experience/knowledge and experience with design verification methods and related equipment for testing medical devices and device constituents of combination products.

Knowledge of the regulatory and compliance requirements of design control for medical devices and/or combination products (e.g. FDA QSR 21 CFR Part 4 and 820 / ISO 13485 and Regulation (EU) 2017/745).

Experienced in and good understanding of lab management in GLP environment supporting, ISO13485, ISO11608, and ISO11040.

Experience with quality engineering principles such as: basic statistics, sampling calculations, incoming and 1st article inspection, and measurement system analysis.

Must have knowledge of industry best practice concerning GLP testing injector (e.g. PFS and Autoinjector) devices.

Excellent written and verbal communication and negotiating skills

Ability to prioritize/report on daily activities or objectives to meet internal and external customer needs on time of established timelines in a fast-paced environment

Experience with hands on root cause investigation of device malfunctions in Prefilled syringes, autoinjectors, on body injectors is a plus.

Experience with design controls V&V testing, Design of Experiments, systems engineering is a plus.

Active ASQ CQE, CRE, and /or Six Sigma certification(s) are a plus.

Education

Bachelor's in Science or Engineering degree required with 5yrs of experience in pharma or medical device industry; preference given to candidates with advanced degree with Five (3) or more years of cGLP/GMP experience; consideration will be given to other relevant experience and education in developing mechanical test methods for combination products (e.g. prefilled syringes, autoinjectors, etc) or working in related roles in Quality Control/Assurance, Design Assurance, Quality Engineering functions supporting design verification and validation of medical devices, or combination products.

qualifications:

Experience level: Experienced

Minimum 5 years of experience

Education: Bachelors (required)

skills:

Quality

QualityEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.