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Job Description

About the Role: We are seeking a highly skilled and experienced Quality Engineer to join our team in the medical device industry. The ideal candidate will have a strong manufacturing background and a proven track record in quality engineering, particularly in the assembly of complex, low-volume medical devices. This role involves close collaboration with various teams to ensure the highest standards of quality and regulatory compliance for post market hemostasis products.

Key Responsibilities:

Reviewing Engineering Change Orders: Evaluate and approve changes to engineering designs and processes, ensuring compliance with medical device regulations.

Attending Standup Operation Meetings: Participate in daily standup meetings to discuss ongoing operations and project updates.

Joining Change Review Meetings for Software: Collaborate with the software team to ensure hardware and software integration is seamless, focusing on medical device functionality.

Design Change Risk Assessments: Conduct risk assessments for design changes to identify potential issues and mitigate risks, adhering to medical device standards.

Supply Chain Issue Resolution: Assist procurement in identifying and resolving supply chain issues, including inventory management, with a focus on medical device components.

Performing Supplier Audits: Conduct FDA audits and ensure suppliers meet regulatory standards specific to medical devices.

Manufacturing Background: Work closely with assembly teams to ensure quality standards are met for medical devices.

GD&T Knowledge: Apply Geometric Dimensioning and Tolerancing principles in quality assessments for medical device components.

ISO 13485 Compliance: Utilize ISO 13485 standards in quality management processes for medical devices.

Assessing Changes Against ISO 14971: Evaluate changes against ISO 14971 standards to ensure risk management compliance for medical devices.

Supporting Hemostasis Product Lifecycle: Focus on maintaining and improving the quality of 'on market' hemostasis products, ensuring their sustainability and compliance.

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

- Bachelors Degree in an engineering discipline or related field (electromechanical)

- Manufactuing background - Experienced working with assemblers

- Ability to read drawings - Tolerance analysis - GD&T (do not need to be certified)

- 5 years of experience with Worked with NCRs and Change reviews - CRBs

- Co-owners for the NCRs and need to understand the change review process

- Assess changes - ISO Standard 14385

- Experience with ISO standard 14971 - SAP experience - can train on this in-house

- Hemostasis experience

- Medical Device / IVD experience

- ASQ CQE or Lead Auditor certified null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].