"Alerted.org

Supplier Quality Engineer 2

Newark, DE, United States

Are you passionate about ensuring quality in manufacturing and supplier processes? Hologic is seeking a Supplier Quality Engineer to oversee supplier quality management, drive continuous improvement, and support regulatory compliance in the medical device industry. If you thrive in problem-solving, process optimization, and cross-functional collaboration, this is your chance to make a difference!

Knowledge:

+ Deep understanding of supplier quality management systems, including regulatory compliance with standards like FDA 21 CFR, ISO 13485, and ISO 9001.

+ Familiarity with the Production Part Approval Process (PPAP) and automotive APQP processes (desirable).

+ Specialized knowledge in medical device regulations, risk management, validations, and root cause analysis (desirable).

+ Expertise in supplier audits, supplier performance metrics, and maintaining supplier quality records.

Skills:

+ Strong communication skills, both verbal and written, to interact effectively across all organizational levels.

+ Ability to use problem-solving tools like SPC and TQM to optimize processes and resolve supplier-related issues.

+ Proficiency in project management techniques to manage multiple complex projects and meet deadlines.

+ High proficiency with Microsoft Office Suite for generating reports, analyzing data, and presenting findings.

+ Ability to negotiate, collaborate, and work independently with minimal supervision.

+ Desirable skills: ISO 13485 lead auditing, PPAP, Agile and Oracle proficiency, and risk management.

Behaviors:

+ Detail-oriented with a strong commitment to ensuring compliance with quality management systems and regulatory standards.

+ Proactive and solutions-focused, driving continuous improvement in supplier processes.

+ Collaborative and team-oriented, working effectively with cross-functional teams and suppliers globally.

+ Organized and able to manage competing priorities in a fast-paced environment.

+ Ethical and customer-focused, ensuring supplier quality directly contributes to patient safety.

Experience:

+ 2+ years of experience in medical device manufacturing or a related industry, with at least 1 year in a Quality Assurance function (desirable).

+ Proven track record of conducting supplier audits, qualifying new suppliers, and managing supplier-related issues.

+ Hands-on experience with complaint resolution, root cause analysis, and implementing corrective actions.

+ Experience coordinating and executing activities related to supplier onboarding, new product introductions, and process improvements.

The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position.

Why join Hologic?

We are committed to making Hologic the destination for top talent. 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.

The annualized base salary range for this role is $76,800- $120,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, 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.

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