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BD · 15 hours ago

Quality Engineer

Columbus, NE

Full-time

Onsite

Mid Level

3+ years exp

BD is one of the largest global medical technology companies in the world, and they are seeking a Manufacturing Quality Engineer to assist in establishing and implementing quality control processes in manufacturing. The role involves developing inspection procedures, monitoring product quality, and ensuring compliance with regulatory standards.

Health CareMedical DeviceTechnical Support

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Develop, change, and supervise in-process inspections to ensure the greatest value in process control for the customer and the plant during the manufacturing process while meeting regulatory requirements

Process monitoring and adjustment, process and product improvement, including corrective action plans to address complaint issues

Documentation of these activities along with the review and maintenance of S.O., O.I.s and department specific operating procedures such as manufacturing cleaning procedures

Employee training of Quality Control concerns regarding Process specifications

Develop and implement procedures applicable to the total plant manufacturing process

Coordinate efforts with Process Engineering, Production for the establishment of controls, which support current product designs, and process capabilities for assigned product lines. Assistance in such areas as process validation, process acceptance, certain audit correction actions, Change Control issuance for process changes

Support CAPAs as owner or as part of the support team

Monitor the performance of assigned product lines about product quality levels, waste, and rejection rates

Leading / mentoring / conducting quality improvement projects thru CI initiatives

May acquire Green/Black Belt Certification

Develop the acceptance and validation of process / equipment

Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality, cost

Assume a role of leadership in analyzing and resolving issues, which prevent desired quality levels achievement

Develop programs for the maintenance, replacement, and improvement of inspection gauging

Stay informed as to the latest requirements of federal regulations and corporate policies regarding medical devices

Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements

Own and continue to improve department training systems

Monitor customer complaints and trends. Respond as needed for specific corrective action and customer interface

Provide support and guidance on quality/ process improvements

Ensure that all company safety rules and regulations are followed and promote general plant safety

Own and lead efforts to reduce and eliminate rejections

Assist in internal/ external audits and supplier certification processes as needed

Other duties as required to support the needs of the business

Qualification

Manufacturing ProcessProcess ControlGMP/Medical DeviceGreen/Black Belt CertificationEDHR SoftwareValidation ProtocolsMicrosoft OfficeIndependent ThinkingEffective CommunicationTeamworkDecision Making

Required

Bachelor's degree required

Three years manufacturing experience with broad background in manufacturing process

Two years Process Control experience

Three years practical GMP/Medical Device manufacturing experience

Effective Oral/written Communication - Proficient

Ability to work as part of a team / Teambuilding - Advanced

Independent thinking / Self Driven - Proficient

Decision Making Ability - Proficient

Computer Skills / Microsoft Office - Proficient

Ability to write programs supporting the implementation of the eDHR project

Ability to read and write and converse in English

Willing and able to uphold BD Values

Preferred

Validations experience, preferred

May acquire Green/Black Belt Certification

Product / process improvements utilizing Green/ Black Belt/Six Sigma techniques

Ability to generate validation protocols, which align with the globalization standardization initiative

Benefits

Competitive pay

Access a portion of your pay before pay day with DailyPay

Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover.

Preventive care covered at 100%.

Dental and vision insurance at group rates.

Paid parental leave up to 6 weeks

Adoption assistance plan

401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation

Company paid basic life and AD&D insurance

Tuition reimbursement

Discounted home, auto and pet insurance

Paid holidays and vacation (pro-rated the first year based on actual start date)

Company

BD

Glassdoor3.9

BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.

Founded in 1897

Franklin Lakes, New Jersey, USA

10001+ employees

https://www.bd.com

H1B Sponsorship

BD has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (66)

2022 (4)

2021 (3)