Quality Technician (Manufacturing)

Select Source International

Marlborough, MA, USA

Published: 6/14/2022

Technology

Full Time

Job Description

Job Title: Quality Technician (Manufacturing)

**Pay Rate: $25/hr on w2**

Location: 445 Simarano Drive, Marlborough MA 01752

Duration: 06 months (possible extension/Conversion)

Shift:1st Shift

Job Summary:

Final Inspector 2 is a critical member of the Quality Assurance team, responsible for ensuring that finished products and in-process components meet all regulatory, quality, and customer requirements before release to inventory.
This role involves the meticulous review of Device History Records (DHRs), performing inspections, and providing support to manufacturing and quality processes, such as Incoming Inspection, Material Review Board (MRB), Calibration and Returned Material Authorization (RMA) activities.
The Final Inspector 2 is instrumental in upholding Hologic’s commitment to excellence by ensuring compliance with Good Manufacturing Practices (GMP), ISO standards, and quality systems, while fostering a culture of continuous improvement and collaboration.

Foundations of Success:

Final Inspector 2 will exemplify the following principles:

Lead with Ownership - Demonstrate integrity and always aim to do the right thing. Be highly accountable for your work, follow through on commitments, and take responsibility when things don’t go as planned. Embrace opportunities to try new things and learn from mistakes.
Act with Speed - Approach tasks with a strong sense of urgency and a bias toward action. Keep stakeholders informed by providing regular updates early and often, ensuring transparency and avoiding unexpected surprises, even when working at a fast pace.
Foster Partnerships - Collaborate effectively with teammates and stakeholders to achieve shared goals. Invest in building strong working relationships and contribute to efforts that fulfill the organization’s Purpose, Promise, and innovative solutions. Engage in proactive communication, provide excellent service, and develop a deep understanding of customer needs to create positive, lasting impressions and build trust-based relationships.
Celebrate WINS! - Take pride in delivering impactful results. Contribute to a positive team environment by celebrating both individual and team accomplishments. Support colleagues, recognize collective successes, and embody the mindset of an 'A-player' who inspires others.

Essential Duties and Responsibilities:

The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

Perform detailed reviews of Device History Records (DHRs) as part of final inspection and release activities for finished products, ensuring accuracy and compliance with documentation standards.
Conduct reviews of manufacturing records for replacement components, subassemblies, and in-process inspections to ensure alignment with quality requirements.
Support manufacturing personnel by ensuring proper documentation of Failure Investigation Reports and processing of Non-Conforming Materials in the Product Lifecycle Management (PLM) system, including identification, quarantine, and documentation.
Perform routine inspections, including field service and special inspections, to support validations, studies, and incoming inspection activities.
Communicate and reinforce Good Manufacturing Practices (GMP) to manufacturing personnel to uphold quality standards.
Review and provide input on new releases of Inspection and Test documents to ensure adherence to Good Documentation Practices (GDP).
Maintain QA Activity Collection Plans, First Pass Yield reports, and other applicable tracking mechanisms to monitor quality metrics.
Collaborate with Engineering to provide feedback on documentation improvements and process changes.
Support Incoming, product returns and calibration teams as needed as needed.
Perform other duties as assigned by leadership to meet organizational and operational needs.
Excellence through Integrity, Compliance, Safety and Environment
Ensure compliance with all company policies and procedures, including safety regulations, Personal Protective Equipment (PPE) requirements, Standard Operating Procedures (SOPs), Quality Management System regulation(QMSR), ISO standards, and Good Documentation Practices (GDP).
Demonstrate a strong commitment to the company's core values, including integrity, respect, collaboration, and innovation.
Actively contributes to a positive and inclusive work environment, supporting colleagues and promoting a culture of mutual respect and teamwork.
Engage in continuous improvement initiatives, striving for operational excellence and efficiency.
Promote sustainable practices within the workplace, including waste reduction, recycling, and energy conservation.
Participate as applicable in workshops, training sessions, and other activities aimed at fostering a culture of continuous improvement and lean thinking.
Participate in regular training and complete all training on time.

Qualifications:

Education:

High school degree and/or an equivalent technical school education preferred.

Experience:

Minimum of 3 to 5 years related Quality Inspection experience in Medical Manufacturing environment.
Experience with Oracle, and Agile preferred.

Skills:

Strong attention to detail and accuracy in reviewing documentation and inspection processes.
Ability to work independently with minimal supervision and make informed decisions.
Excellent interpersonal and communication skills for effective collaboration across teams.
Thorough understanding and application of Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
Familiarity with quality management systems (QMS) and regulatory requirements in the medical device industry.
Ability to interpret engineering drawings, specifications, and technical documentation.
Proficient in using quality tools, metrics, and software systems, including Oracle and Agile (preferred).
Organizational skills to maintain accurate records, logs, and reports.
Commitment to continuous improvement and fostering a culture of operational excellence.

Physical Demands:

The physical requirements described here are representative of those that must be met by an employee to successfully perform

the essential functions of this job.

Sit; use hands or fingers, to handle or feel objects, tools, or controls.
Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
Lifting/pushing/pulling and carrying products weighing up to 45 pounds
Potential Exposure to moving mechanical parts, vibration and/or moderate noise levels.
Potential Exposure to hazardous chemicals or other materials.
Safety Shoes compliant with site specific policies/procedures must be worn in designated areas
Potential Exposure to blood.
Exposure to biological specimens (biohazards).
Other (please specify): Hepatitis B vaccination required.
Exposure to biological specimens (biohazards).

\nCompany Description

As a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier diversity.

Company Description

Select Source International (SSI) is a distinguished workforce solutions provider with nearly 25 years of experience delivering top-tier staffing, recruiting, and managed services. Based in Minneapolis, Minnesota, SSI has established itself as a global leader, serving a broad, diverse clientele across industries with unwavering dedication and excellence.\r\n\r\nAs a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier diversity.