Quality Engineer II

Adecco Healthcare and Life Science is hiring for a Lab Quality Engineer Arden Hills, MN. Apply today if you meet the qualifications listed below!

Location Arden Hills, MN Duration: 12 month contract (possible Temp-to-Hire) Schedule: Monday - Friday 8am - 4:30pm Pay rate: $50/hour

This position serves as Quality Assurance or Quality Engineer, as applicable, for internal Boston Scientific procedures and preclinical laboratory studies, and conducts internal and external quality reviews to ensure compliance with regulatory requirements and company policies.

Responsibilities will include:

• Support laboratory functions to maintain compliance with applicable regulations
• and standards, validated methods, and internal policies, procedures and work
• instructions, while promoting continuous inspection readiness.
• Collaborate with quality management and laboratory management on process
• improvement initiatives, quality trends and continuous improvement projects.
• Conduct internal and external quality assurance audits of systems, testing
• laboratories, procedures and controls used in testing activities under applicable
• regulations and standards.
• Plan, schedule and conduct vendor audits.
• Partner with global preclinical teams and Strategic Sourcing regarding new vendor
• requests and ongoing vendor needs.
• Evaluate the adequacy and compliance of systems, operations and practices
• through facility- and process-based audits and quality monitoring activities.
• Assess the accuracy, validity and overall quality of preclinical study data.
• Communicate final results of quality reviews and audits to management and
• technical staff.
• Write and publish audit and quality review reports, obtain appropriate approvals and
• distribute findings to responsible stakeholders.
• Oversee follow-up of corrections and corrective actions, escalate overdue items
• and support timely closure.
• Support or lead assigned quality projects and initiatives.
• Track audits and responses, support document review activities and maintain
• appropriate records.
• Contribute to the development and continuous improvement of quality procedures
• and processes.
• Assist laboratories in preparation for accrediting body, notified body, FDA or other
• regulatory inspections.
• Support the preclinical organization in meeting Boston Scientific Quality System
• requirements.
• Support the CAPA process in partnership with CAPA owners.
• Support compliance review meetings in accordance with site procedures.

Qualifications:

• Bachelor’s degree in chemistry or related life sciences discipline
• Strong technical and quality knowledge of ISO/IEC 17025, ISO 13485 and/or 21 CFR 58
• Strong verbal and written communication skills, both technical and conversational
• Minimum of 3 years' experience in a technical role

Preferred qualifications:

• Minimum of 2 years' experience working in a quality role
• Minimum of 4--5 years' experience working in the medical device industry or other similarly regulated industry, such as pharmaceuticals, biologics or preclinical environments
• Strong experience with 21 CFR 58 (GLP)

Why work for Adecco? · Weekly Pay · 401(k) Plan · Skills Training · Excellent medical, dental, and vision benefits

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria. IMPORTANT: This job is being recruited for by Adecco’s Healthcare & Life Sciences division, not your local Adecco Branch Office. For opportunities available at Adecco Healthcare & Life Sciences go to www.adeccousa.com/industries/medical-and-science Equal Opportunity Employer/Veterans/Disabled. To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit http://www.adeccousa.com/candidate-privacy/. The Company will consider qualified applicants with arrest and conviction record.

Pay Details: $50.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.