Jobs for People with MS: National MS Society

Director, Manufacturing Quality

Newark, DE, United States

Hologic's Quality team supporting our Breast and Skeletal Health Division is seeking a Director, Manufacturing Quality ensuring medical devices and components are manufactured in accordance, to ISO standards such as, 21CFR820 and ISO13485. As the Director, Manufacturing Quality you will be responsible for activities related to the current good manufacturing processes (cGMP), assuring smooth operations of the divisional manufacturing quality processes. If you are qualified for this role, apply today !

What We Expect:

Establish operational objectives and work plans, and delegate assignments to subordinates. You will be expected to provide direction in terms of costs, methods, and staffing. Along with resolving issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. You will expected to implement strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.

What To Expect:

• Ensure compliance with all applicable standard operating procedures and regulations, including under 21 CFR Part 820, ISO 13485:2016, EU Medical Device Regulation, etc.

• Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.

• Define sampling plans and approves inspection methods for evaluation and acceptance of components and finished product.

• Provide support in the revision and maintenance of PEMEAs, Quality control plans, process instructions and additional manufacturing documents.

• Evaluate the need of risk mitigation techniques given product classification, potential types of defects, defect frequency, severity, risk for the patient, process capacity, process controls, etc.

• Determine the effectiveness of these techniques in the previously implemented improvements.

• Revise, approve, execute IQ, OQ, PQ, TMV, and DOE

• Coordinate in process inspection, DHR review, and product release.

• Establish systems to document and maintain process validation and drawing compliance

• Responsible for the investigation of product and process quality and manufacturing issues.

• Prioritize quality engineering projects and assignments for completion by the appropriate QA personnel.

• Perform periodic non-conformance trend analysis and makes recommendations and reviews associated action plans for NC reduction.

• Leads site validation activities related to initiating new lines and process improvements.

• Works with R&D, process engineering, and manufacturing engineering departments to develop, conduct and approve product and process validation strategies of products and processes.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $150,900 -$268,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

LI-#DS1