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Instrumentation Laboratory - Bedford SW Quality Engineering Manager in Bedford, Massachusetts

Instrumentation Laboratory

Our Passion. Your Results.

Founded in 1959, Instrumentation Laboratory (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, patient blood management and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing medical professionals the most valuable and complete solutions to enhance patient care.

As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostic products, IL is supported by significant resources, outstanding scientific expertise and a tremendous knowledge base. IL is headquartered in Bedford, MA, USA.

Position Summary:

Leads a team of software engineering quality professionals to advise and assist in developing, applying and implementing methods, tools and practices to achieve product quality goals and requirements in the areas of production software and validation, distribution of software products, maintenance and support of on-market IL products. Provide direction and leadership in the areas of software design changes. Support the organization as needed in the areas of software requirements, development and test, design transfer, and documentation as well as software risk management and trace files. Assures compliance with applicable international and domestic medical device regulations related to software and controls relevant processes through procedures, work Instructions and forms.

Key Accountabilities:

  • Provides direction from a quality control perspective for cross functional interactions regarding process and product compliance/quality optimization.

  • As a core team member product performance investigations teams and on major product changes, the Quality Engineering Manager provides guidance on tools and techniques available for both performance investigations teams and product teams and provides guidance on compliance

  • Provides input to product requirements, acceptance criteria, process monitoring, product evaluation, failure investigation and complaint analysis.

  • Proactively works to improve QMS by recognizing issues working with the Quality System department and multi-functional teams to resolve them.

  • Ensures application of sound statistical methods and quality tools in the evaluation and documentation of results related to design control, purchased part qualifications, V&V, risk analysis, production transfer, production, management of quality systems, distribution and marketing of IL products.

  • Directly participates in product/production investigations to ensure teams understand quality techniques, and apply appropriate tools to solve problems.

  • Provide oversight and approval in change and defect review boards for products and software. Assure disposition of non-conforming material in a timely fashion.

  • Work with manufacturing, R&D, Service, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective I preventive actions (CAPA).

  • Review and approve change orders for product, process, labeling and marketing communications as required.

  • Manage and supervise the work of direct reports.

  • Other duties as assigned

Budget managed (if applicable): N/A

Internal Networking/Key relationships:

  • To be determined based on department needs

Skills & Capabilities:

  • Ability to manage and coordinate the activities of direct reports

  • Excellent communication skills are required to facilitate cooperation among various internal groups, as well as outside agencies, suppliers, and customers

  • Ability to apply, review and interpret statistical methods in alignment with QMS and industry quality standards

Min Knowledge & Experience required for the position:

  • Bachelor's degree in engineering or science, advanced degree preferred.

  • Minimum of 3 years of experience in medical devices, pharmaceuticals, diagnostic industry or clinical laboratory

  • Minimum of 5 years in a Supervisory Role directly responsible for production and production quality

  • Duties necessitate broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design engineering

International Mobility: Required: no

Travel requirements: No

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Instrumentation Laboratory appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

Werfen is a global leader in in vitro diagnostics (IVD) in the specialities of Hemostasis, Acute Care Diagnostics and Autoimmunity. Our core business is dedicated to R&D, manufacturing and distribution of diagnostic systems for hospitals and clinical laboratories. Our other areas of expertise include Original Equipment Manufacturing, Clinical Software, Clinical Chemistry, Infusion Therapy, and Medical Devices and Scientific Instrumentation Distribution.

We operate directly in over 30 countries and in more than 100 territories through distributors. In 2016, our turnover was approximately 1.2 billion euros and we had an average workforce of 4,400 people. Currently, we are over 5,000 employees.

Job ID: 2019-2619

Shift: 1st

Street: 180 Hartwell Road