Quality Engineering Manager
SAN DIEGO, CAPosted 30+ days ago
Job summary
Job post source
This job is directly from Ascential Medical and Life Sciences, part of Burke Porter, an Ascential Technologies Company.
Job overview
The Quality Engineering Manager leads the Quality Engineering team to ensure product quality and regulatory compliance in medical device and life sciences projects, driving innovation and safety.
Responsibilities and impact
The role involves leading and mentoring the Quality Engineering team, overseeing design controls, risk management, process validation, supplier quality, CAPA, compliance with FDA and ISO standards, and supporting manufacturing process transfers.
Compensation and benefits
The position offers an annual salary range of $132,000 to $165,000 based on experience and qualifications, along with a comprehensive benefits package.
Experience and skills
Candidates need a Bachelor's degree in Engineering or related field, 7-10 years in Quality Engineering in life sciences, 3-5 years management experience, Six Sigma certification, and expertise in FDA and ISO regulations.
Work environment and culture
The company fosters a culture of quality and continuous improvement, emphasizing collaboration, leadership, and adherence to core values.
Company information
Ascential Medical and Life Sciences delivers precision engineering and automation solutions for medical devices, diagnostics, and life sciences, and is part of Burke Porter, an Ascential Technologies Company.
Team overview
The candidate will lead a multidisciplinary Quality Engineering team, managing resources and collaborating cross-functionally with R&D, manufacturing, and supply chain teams.
Job location and travel
This is an on-site position located in San Diego, with limited travel required.
Unique job features
The role includes leadership in regulatory compliance, quality system management, and involvement in complex projects including manufacturing process transfers and continuous improvement initiatives.
Company overview
Universal Balancing, now part of Burke Porter Group under Ascential Technologies, specializes in advanced balancing solutions for industries such as automotive, aerospace, and manufacturing. The company designs and manufactures precision balancing machines and systems, enabling clients to enhance operational efficiency and product quality. With a history rooted in innovation, it became a trusted name in global markets before its acquisition by Burke Porter, a leader in intelligent testing and assembly solutions. This integration reflects a strategic focus on expanding technological capabilities and global reach.
How to land this job
Position your resume to highlight leadership in Quality Engineering, emphasizing team management, mentoring, and development aligned with business objectives, as this is central to the Quality Engineering Manager role at Universal Balancing (Burke Porter).
Emphasize expertise in FDA QSR (21 CFR 820), ISO 13485, ISO 9001 compliance, risk management per ISO 14971, design controls, process validation, supplier quality, and CAPA processes, reflecting core responsibilities described in the job description.
Apply through multiple channels including the Burke Porter corporate careers page, LinkedIn, and specialized life sciences or medical device job boards to maximize exposure and increase your chances for this specialized role.
Connect on LinkedIn with current Quality Engineering leaders or team members at Universal Balancing/Burke Porter; use ice breakers like commenting on recent product launches, innovations in medical device quality systems, or asking about their approach to regulatory audits to start meaningful conversations.
Optimize your resume for ATS by incorporating keywords such as 'Quality Engineering Manager,' 'FDA QSR 21 CFR 820,' 'ISO 13485,' 'risk management ISO 14971,' 'process validation IQ/OQ/PQ,' 'supplier quality management,' and 'CAPA,' ensuring your resume passes automated screening.
Utilize Jennie Johnson's Power Apply feature to automate tailored applications across multiple platforms, identify LinkedIn contacts to network with, and fine-tune your resume for ATS, allowing you to focus your energy on preparing for interviews and strategic networking.
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