Quality Senior Engineer I Jobs

·Proficient in project management, data analysis, root cause analysis, communication, and risk determination

·2 years of relevant experience in a regulated industry (FDA environment preferred)

·Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard

·Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.

·Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation

·Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization

Knowledge of Microsoft Office products (Word, Excel, PowerPoint, Access) or equivalent software

Associates degree OR HS Diploma/GED and an additional four years of experience.

Responsible for preparing quality assurance documents, training documents, workflows, standard work, and visual media for the team.

Provides support for the development, implementation, and documentation of quality assurance.

Attends and participates onsite to support program areas as needed.

Collaborates with team members for process improvement suggestions.

The entire aspect of customer complaint management

You have excellent organizational skills and can manage multiple tasks with varying deadlines

the entire aspect of customer complaint management

You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)

Bachelor’s degree or equivalent experience required

Minimum of 1-3 years Nuclear Medicine/PET and/or medical device industry experience

Disability Benefits (short term and long term)

Supplemental benefit programs: critical illness/accident hospital indemnity/group legal

Joining our team comes with amazing perks and benefits:

Additional sick leave beyond what state and local law require may be available but is unprotected

Life and Accidental Death Insurance

Preferred Knowledge, Skills And Abilities

Provide required training to support qualification activities

Assume the QA responsibilities for reviewing and approval of validation life cycle documentation (PDD, IOQ/PQ protocols, protocol addendums, summary reports, etc.)

Keep current with all Industry standard practices and FDA requirements for validation, change control and complaint handling

Bachelor’s degree or equivalent experience in a technical discipline including Biology/Microbiology, Chemistry or Engineering

6 - 10 Years of experience

Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Responsibilities may include the following and other duties may be assigned.

2+ years of medical device quality experience, with a focus on daily operations and manufacturing quality.

Prior experience providing mentorship to lower level quality engineers.

Experience supporting NPI and production expansion projects.

1-2 years of management experience.

Financial responsibilities and accountabilities include department and capital budgeting and expenditures for areas of responsibility.

Serve as deputy Site Management Representative, as needed.

Excellent command of process validation and risk management for medical device.

Assigns and manages the work of self and direct reports to:

Author, review and implement the quality systems procedures in several sections or departments and manages compliance to the system.

Coordinate audits of our facility as outlined within the Quality Management System in support of the applicable ISO Standards.

Improve response to ISO audits of our facilities to ensure conformance to requirements.

Manage internal audits that optimize plant operations.

Manage and coordinate activities of the process laboratory and laboratory colleagues.

Several years’ experience in managing quality systems and labs in an ISO 9001 environment.

Develop, implement, and improve effective Quality Control Methods and Procedures necessary to support ISO Quality System.

Working knowledge of digital product design and user experience.

BS degree in Computer Science or equivalent practical experience.

5+ years of software development experience.

4+ years of experience with any of the following: React, Angular, Redux, Node.js

Experience with responsive web design and the ability to deliver across devices and platforms.

Strong communication skills and attention to detail.

Previous experience with InfinityQS Statistical Process Control (SPC) software, Microsoft Project, or related project management software is preferred

Bachelor's degree in Engineering, related field, or equivalent combination of education and experience

Experience with JMP or similar statistical analysis software preferred

Knowledge of LEAN Manufacturing techniques/principles and implementation is strongly preferred

Experience with an ISO9001 organization, manufacturing plastics and/or polyurethane is preferred

Experience with extrusion, injection molding, and thermoforming processes is a plus

• Education Preferred: Bachelor’s in Engineering or an equivalent discipline.

• Years of Experience Required: 2-3 years

: **Visa sponsorship is not available, now or in the near future, for this position**

Able to prioritize and communicate well with others

Minimum 1 year experience working with Quality Management Systems

Bachelor’s Degree in Engineering, physical sciences or related from an accredited university or college, or equivalent education and experience

Demonstrated ability to work with all levels of employees, management, suppliers and OEMs

Interpret data for senior leadership and manage expectations at all levels

Strong technical aptitude and analytical skills, including engineering tools and systems

Strong interpersonal skills, ability to guide and influence others, and strong team player

Proven experience in Supplier management, involving document review, audits, PPAP, and SICR.

Proficient with ISO 9001:2015 standards, showcasing an understanding of quality management systems.

Quality Management Review: Actively participate in Quality Business Reviews (QBR) and Supplier Management Review activities.

Demonstrate a minimum of 4 years' hands-on experience in either wireless or medical device industries.

Exhibit excellent organizational and communication skills, both written and verbal.

Possess knowledge of manufacturing processes for molded plastic parts and electronics assembly of printed circuit boards.

Knowledge of Agile/Scrum/Kanban development processes

Defining automatic tests for the whole environment

Implementing or identifying relevant test cases (acceptance, integration, etc.)

Sharing the automation sets and tools with the rest of the development team

Analyzing test results, preparing summary reports, and providing fixes/improvements to the team based on that feedback

Carrying out both testing tasks and development tasks

Life insurance, short term disability, educational reimbursement, flex spending and employee stock purchase plan

3+ weeks of paid time off plus 10 paid holidays

Medical/dental/vision for employee and dependents at a discounted rate

401K (we match 100% at 6% contribution level)

This position will work in an office setting, expect minimal physical demands.

Learn More About Our Company

Manage projects including key responsibilities for scheduling and coordination of project resources to meet client and organizational needs.

Minimum of 7 years of environmental consulting experience.

Holds professional certification as a P.E., or absent certification, a minimum of 7 years working with a licensed professional.

Experience performing conceptual and detailed remedial design work.

Advanced data evaluation and analytical skills.

Proficient written and verbal communication skills.

Manage projects including key responsibilities for scheduling and coordination of project resources to meet client and organizational needs.

Minimum of 7 years of environmental consulting experience.

Holds professional certification as a P.E., or absent certification, a minimum of 7 years working with a licensed professional.

Experience performing conceptual and detailed remedial design work.

Advanced data evaluation and analytical skills.

Proficient written and verbal communication skills.

Knowledge of statistics, design of experiments, sampling, gauge R&R, FMEA/risk management and process control.

Intermediate to advanced knowledge of MS Office Suite and statistical software, Minitab experience preferred

Knowledge of applicable regulatory standards, specifically ISO 13485 or possess the ability to understand and enforce the practices.

Knowledge of ISO 17025 and FDA Regulation 21 CFR Part 820 is a distinct advantage

Strong problem solving and analytical skills, with concentration on risk analysis;

Demonstrated project organizational skills required

Project management skills. Use of PMO tools

Preferred industry experience: third party logistics, drug distribution, PBM, and/or distribution finance, manufacturing quality

Manage KPI reporting and program scorecards to monitor program performance, identifying and actioning opportunities for improvement.

Use data to identify opportunities and drive operational improvement, in partnership with the Account / Program Manager

5-7 years of experience of directly leading initiatives for a fortune 500 company

Working knowledge of ISO, IATF (TS), CGMP, CAPA or other quality processes

Manage process verification and validation activities according to FDA and all other global regulatory agency requirements

Participate with Supply Chain to select suppliers, manage the audit and qualification of new suppliers

Essential Job Duties & Responsibilities

Establish and implement effective process controls and product test requirements

6+ years of experience working within the medical drug/device regulated industry (e.g. FDA, ISO)

Demonstrated ability to effectively manage multifaceted projects and to resolve complex quality-related issues