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Sr Quality Engineer

No Haven, CT 06473

Posted: 08/01/2024 Employment Type: Contract Job Category: Engineering Job Number: 612496 Is job remote?: No Country: United States

Job Description


Top 3 technical  skills that you are required for the role:
  1. Design Failure Modes and Effects Analysis
  2. Reliability Engineering Testing and Test Development Knowledge
  3. Provide inputs into system requirements

Education Required: 
  • Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality close

Years’ Experience Required:  4+ years

We are looking for a dynamic and adaptive Sr. Quality Engineer with the desire to be part of the fast-growing Surgical Innovations business helping us to ensure they exceed the safety and reliability requirements and expectations of patients clinicians regulators and the business. This position provides reliability and quality engineering support on new development projects. The candidate will be a key player in cross-functional teams and serve as a compliance and technical representative for reliability safety and quality functions.

As part of Quality project teams the Sr. Quality Engineer will define contribute and execute the quality plan for ensuring compliance to regulatory requirements. This position will collaborate with multidisciplinary teams and provide guidance to technical issues engagement in design and risk reviews and contribute to development activities.
 
TECHNICAL SKILLS
Must Have (In addition to the top 3 listed above)

  • Experience in Risk Documentation: Write, review, approve of Riks Management files, RPM calculations, Risk Mitigations, etc. Sampling size determination: For Attribute or variable data
  • Strong statistical background
  • Able to work with minimum of supervision in a hybrid working organization set up
  • Good writing and documentation skills.
  • Good organizational and verbal communication skills.
  • Ability to work in fast-track schedule and meet deliveries on time.
  • Ability to communicate effectively.
  • Ability to interact with a very diverse team keeping high ethics standards.
  • Demonstrate commitment with the company's Core Values.
  • Experience working in large organization with cross-functional peers.
  • Proficiency with Microsoft Office applications, Word, PowerPoint, Teams, OneDrive
  • Proficient and Effective use of Microsoft Excel and knowledge of advanced formulas to manipulate data.
  • Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO9001, 13485, and 14971 requirements.
  • Knowledge of Reliability Testing and development, analytical tools, and methods, including Statistical Quality Control/Statistical Process Control (Minitab preferred), Design Of Experiments (DOE) and the use of computer/software packages related to reliability, design, development, and manufacturing.
  • Reliability Plan development and implementation
  • Traceability Matrix Reliability

Nice To Have
  • Compiles and analyzes performance reports and process control statistics.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer, and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • Develops, coordinates, and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills.
  • Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude.
  • Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).
  • High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning. •
  • Good interpersonal skills: Ability to work effectively in a team environment and build strong working relationships. Effective communication skills, both written and oral and must be computer literate.
  • Experience working in a regulated industry with knowledge of common applicable standards for ablation systems like 60601-1 (electrical safety), 14971 (risk mgmt.)
  • Understanding of the product development process including methods for determining design inputs, evaluating multiple designs, and designing, executing the appropriate verification and validation tests, completing risk management deliverables, gaining internal and regulatory approval, and launching new products.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About No Haven, CT

Ready to take your career to new heights? Explore job opportunities in the vibrant area around New Haven, Connecticut! Known for its rich history, academic excellence, and diverse culture, this region offers endless growth potential to job seekers. Home to Yale University, the Shubert Theatre, Pepe's Pizza, the New Haven Green, and the picturesque East Rock Park, New Haven provides a perfect blend of intellectual stimulation and scenic beauty. Don't miss out on joining this dynamic community and advancing your career in one of the most enchanting cities in the Northeast! Check out our job listings today and start your professional journey in the heart of New England.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.