Quality Assurance Engineer

Millar, Inc Located in: Houston,  Texas
(Private and Secure - Guaranteed!)

Millar, Inc Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Come be a part of a dynamic team that is helping to make the improbable possible through innovation, customer relationships and support of our novel catheter-based, pressure sensing and telemetry technology, which is utilized worldwide in medical research, diagnostics and clinical treatment.

Millar works directly with customer and business partners to help push medical discovery to the next level.  From mouse to man, our company plays an important role in medical discovery at every level.  Join Millar during an exciting period of growth, as we take the opportunity to expand our clinical and research markets and leave a lasting impact on the medical community.

Supports Quality Assurance and Regulatory Audits (“RA/QA”), Engineering, and Manufacturing with inspection, qualification, verification and validation activities. Assists with the maintenance of the Quality System in accordance with documented procedures, quality standards, and regulatory requirements.

Essential Responsibilities & Duties

Assumes primary responsibility in leading cross-functional teams for new product launches.

Ensures quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.

Reviews software project products to ensure compliance to the Quality Management System and adherence to appropriate CDRH and EN software development external standards and guidance documents.

Participates in quality and regulatory audits, root causes analysis for software-related failures, and represents RA/QA Department, when necessary.

Responsible for collaborating with design engineers and other functional stakeholders during the Design and Development phase of New Product Development (NPD) to ensure the following have been addressed prior to a released design:

o   Proper identification of all safety and performance critical components.

o   Identification of all key characteristics along with applicable tolerances.

o   Review Failure Mode and Effects Analysis (FMEA) events as a means of mitigating potential causes of product failures.

o   Responsible for collaborating, as appropriate, with design engineers, suppliers, sustaining engineers, and other functional stakeholders during the Pre-Production phase of New Product Development (NPD) to ensure the following have been addressed prior to launch:

§  Failure Mode and Effects Analysis (FMEA) events as a means of mitigating potential causes of process failures.

§  If applicable, development of control and test plans.

§  Evaluation of gage repeatability and reproducibility (Gage R&R).

§  Process Readiness audits, as needed, at Millar or at off-site supplier locations.

§  Coordinates First Article Inspection approval submissions in conjunction with Buyers, helping to communicate expectations of the FAI to suppliers.

§  Responsible for collaborating with design and sustaining engineers in the monitoring of product quality performance (through feedback loops such as: Postmarket surveillance, returns data, repairs, complaints, etc.) 

§  Lead efforts in driving continuous performance improvement for all products.

§  Participates in Engineering Change Notice (ECN) activities and represents the quality function, as appropriate.

§  Serves as an expert technical resource to Millar product quality as required.

  • Maintains “best-practices” repository and champions the use of best practices as a key input into product design through risk assessment, FMEA, and V&V.
  • Other tasks, duties and responsibilities as assigned.

CRITICAL REQUIREMENTS

  • ·       Four-year technical degree, preferably Biomedical Engineering, and 3 to 5 years.

    ·       Experience: 5+ years in medical device manufacturing and/or quality.

    ·       Medical Device Industry experience required.

    ·       Experience with cardiovascular products a plus.

    ·       Knowledge of FDA (21CFR 803/806/820), EU Medical Device Directive 93/42/EEC ( M5), and ISO (ISO:13485) regulations.

    ·       Preferred Training: V&V, FMEA, statistical techniques, Gage R&R, quality auditing, problem solving, and Six Sigma, Lean.

    ·       Project management and negotiation skills.

    ·       Recommended Credentials: CQT, CQE, and CSQE.

    ·       Influencing skills and the ability to lead cross-functional teams a must.

    ·       Must be able to interface effectively across multiple functions and at various levels of the organization.

    ·       Travel approximately 10% domestically and internationally.

COMPANY INFORMATION

Millar, Inc. provides innovative physiological monitoring solutions to the medical science community that offer insight by delivering unparalleled accuracy. Our expertise in novel device design, manufacturing and depth of understanding of customers’ applications enables us to provide tools for facilitating scientific discovery and medical diagnosis. With our proven Mikro-Tip® pressure and pressure-volume catheter lines, our pressure-volume (PV) loop systems and revolutionary wireless implantable animal telemetry system, we strive to provide clinicians and researchers with the most exact physiological solutions for complete insight from mouse to man.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Quality
Preferred Industry Background:
  Medical Device,  Biotechnology,  Research
Managing a team of:
N/A
Required Travel:
Not at all

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
Education Required:
Any
Therapeutic Experience:
Cardiovascular
International Experience:
North America